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    Summary
    EudraCT Number:2019-001879-37
    Sponsor's Protocol Code Number:GB1275-1101(KEYNOTE-A36)
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-001879-37
    A.3Full title of the trial
    A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label, Dose Escalation Study of GB1275 Alone and in Combination with Anti-PD 1 Antibody in Patients with Advanced Solid Tumors or in Combination with Standard of Care with Patients with Metastatic Pancreatic Adenocarcinoma, Followed by a Dose Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Metastatic Solid Tumors
    A.4.1Sponsor's protocol code numberGB1275-1101(KEYNOTE-A36)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04060342
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGB006, Inc., a wholly-owned subsidiary of Gossamer Bio, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGB006, Inc., a wholly-owned subsidiary of Gossamer Bio, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB006, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
    B.5.2Functional name of contact pointClincial Trials
    B.5.3 Address:
    B.5.3.1Street Address3013 Science Park Road,
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrials@gossamerbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2259
    D.3 Description of the IMP
    D.3.1Product nameGB1275
    D.3.2Product code GB1275
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2055362-74-6
    D.3.9.2Current sponsor code GB1275
    D.3.9.3Other descriptive name Choline salt of leukadherin-1 (LA-1)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KEYTRUDA (Pembrolizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePembrolizumab
    D.3.2Product code Pembrolizumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codePEMBROLIZUMAB
    D.3.9.3Other descriptive namePEMBROLIZUMAB
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2259
    D.3 Description of the IMP
    D.3.1Product nameGB1275
    D.3.2Product code GB1275
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2055362-74-6
    D.3.9.2Current sponsor code GB1275
    D.3.9.3Other descriptive name Choline salt of leukadherin-1 (LA-1)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2259
    D.3 Description of the IMP
    D.3.1Product nameGB1275
    D.3.2Product code GB1275
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2055362-74-6
    D.3.9.2Current sponsor code GB1275
    D.3.9.3Other descriptive name Choline salt of leukadherin-1 (LA-1)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Phase 1: Advanced solid tumors, metastatic pancreatic adenocarcinoma

    Phase 2: Specified metastatic solid tumors
    E.1.1.1Medical condition in easily understood language
    Phase 1: Advanced, abnormal mass of cancerous tissue and cancer of the pancreas that has spread to other parts of the body
    Phase 2: cells that break away from original solid tumor and form new tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the Dose Escalation phase of the study is to determine the MTD or RP2D of GB1275 monotherapy and GB1275 in combination with pembrolizumab or in combination with nab-paclitaxel and gemcitabine through evaluation of safety and PK.

    The primary objective of the Basket phase of the study is to assess the efficacy of GB1275 in combination with SOC or pembrolizumab through determination of objective response rate (ORR) within each basket expansion cohort.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the Dose Escalation phase:

    1) To further assess the efficacy and evaluate the safety and tolerability of GB1275 in combination with SOC (nab-paclitaxel and gemcitabine) as the first line therapy in subjects with newly diagnosed metastatic pancreatic adenocarcinoma

    2) To assess the PK of GB1275 in subjects with newly diagnosed metastatic pancreatic adenocarcinoma

    The secondary objectives of the Basket phase:

    1) To further assess the efficacy and evaluate the safety and tolerability of GB1275 in combination with pembrolizumab in subjects with MSS metastatic colorectal adenocarcinoma or recurrent/metastatic gastric/GEJ adenocarcinoma with PD-L1 expression

    2) To assess the PK of GB1275 in subjects with MSS metastatic colorectal adenocarcinoma or recurrent/metastatic gastric/GEJ adenocarcinoma with PD-L1 expression

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects at least 18 years of age at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
    2. For Regimen A and Regimen B: subjects with histologically or cytologically confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma, or esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or gastric/gastroesophageal junction adenocarcinoma, or TNBC, or metastatic castrate resistant prostate cancer, or MSS colorectal adenocarcinoma.
    Notes: for colorectal adenocarcinoma subject, a documented MSS tumor determined by CLIA-approved local laboratory is required for enrollment.
    3. For Regimen C: the subject must have histologically and/or cytologically confirmed adenocarcinoma of the pancreas and has a diagnosis of stage IV adenocarcinoma of the pancreas (American Joint Committee on Cancer [AJCC] stage IV).
    4. Subjects who have exhausted potential curative options and who are relapsed or refractory to, or intolerant of, or refuse one or more of the approved or standard of care established therapy known to provide clinical benefit for their condition.
    Note: there is no limit to the number of prior treatment regimens.
    5. Subject must have a site of disease that is amenable to biopsy, and be a candidate for tumor biopsy prior to the first dose of the study drug to be considered for the study. Exceptions may be granted after documented discussion with the sponsor. For subjects whose baseline tumor tissues do not contain tumor cells, submission of Formalin-fixed, paraffin embedded (FFPE) or slides (minimum of 15) from archival tissues that were collected within one year prior to the first dose of the study (if available) may be requested.
    6. Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
    7. Demonstrate adequate organ function as defined below. All screening laboratories for organ functions should be performed within 14 days of initiating the study drug(s).
    8. Male or female. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    9. Women of childbearing potential must have negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to receiving the first administration of the study drug(s) and a negative urine pregnancy test on Cycle 1 Day 1 before first administration of the study drug if screening serum pregnancy test was done more than 3 days prior to the first administration of the study drug(s). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
    10. Women of non-childbearing potential: Evidence of post-menopausal status. Refer to Appendix 4 (Section 10.4) for definitions.
    11. Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception. Refer to Appendix 4 (Section 10.4) for contraception guidance.
    12. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use male condoms as described in Appendix 4 (Section 10.4).
    13. The subject (or legally acceptable representative if applicable) provides written informed consent for the study which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    14. For subjects enrolled into Phase 1 Expansion with Regimen B or Dose escalation Phase with Regimen C, the subject has 1 or more tumors measurable per RECIST v1.1 as assessed by the local site Investigator/radiology besides the ones that would be biopsied. Subjects with CRPC who have measurable PSA and bony disease only to be enrolled into Phase 1 Expansion with Regimen B.
    15. For subjects enrolled in Phase 1 Dose Escalation for Regimen A & B or Phase 1 Expansion with Regimen B: Subjects with tumor types that have CPI approved for the indication must have developed disease progression after receiving initial treatment benefit .This includes subjects with gastric/GEJ cancer, esophageal cancer and TNBC in addition to NSCLC, SCLC, HNSCC, RCC, UC, and HCC, etc.. Note: melanoma patients not to be enrolled into Phase 1 Expansion
    16. Subjects with gastric/GEJ cancer, esophageal cancer, TNBC, locally advanced or metastatic PDAC, MSS CRC, and CRPC who have either received prior CPI or have never received CPI.
    E.4Principal exclusion criteria
    1. Has a history of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years.
    2. Has untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
    3. Any unresolved Grade 2 or greater reversible toxicity from previous anticancer therapy except alopecia or Grade 2 neuropathy.
    4. Clinically significant cardiovascular disease.
    5. Has an active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 14 days of Cycle 1 Day 1.
    6. Pregnant or nursing.
    7. Known history of testing positive for human immunodeficiency virus (HIV), and/or positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
    8. A serious nonmalignant disease (eg, psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
    9. Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
    10. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
    11. Malabsorption syndrome.
    12. Has active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of study drug(s) (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drugs).
    Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    13. A history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    14. Undergone major surgery within 4 weeks and have wound(s) not healing completely prior to Cycle 1, Day 1.
    15. Received prior systemic anticancer therapies within 4 weeks of biologics and 2 weeks of chemotherapy or targeted small molecule therapy or herb supplements that are used for the treatment of the malignancy under the study (6 weeks for nitrosoureas or Mitomycin C) prior to study treatment.
    Note: Prior systemic anticancer therapy is not allowed for subjects to be enrolled into Pancreatic Adenocarcinoma Expansion Cohort 1.
    16. Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of
    radiotherapy) to non-CNS disease.
    17. Previously received treatment with a myeloid targeting agent for example a CSF1R inhibitor or a CCR2/5 inhibitor.
    18. Use of medications that are known to definitely prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) within 14 days of Cycle 1 Day 1
    19. Use of amiodarone within 90 days prior to Cycle 1 Day 1.
    20. Received a live vaccine within 30 days prior to the first dose of study drug(s). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
    21. Received OATP 1B1/1B3 substrates such as pitavastatin, simvastatin, fexofenadine, and bosentan within 14 days of Cycle 1 Day 1.
    22. Received inhibitors and inducers of CYP3A and CYP2C8 inhibitors (eg, gemfibrozil, clopidogrel, teriflunomide, deferasirox, telithromycin, trimethoprim) or inducers (eg rifampin) within 14 days of Cycle 1 Day 1.
    23. Prior history of inability to tolerate anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
    24. Has had an allogeneic tissue/solid organ transplant.
    25. Immunosuppressive doses of systemic medications, such as steroids (doses > 10 mg/day prednisone or equivalent daily) within 2 weeks before study drug(s) administration for active autoimmune disease.
    26. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug(s).
    27. Subjects in Phase 1 Expansion with Regimen B only with tumor types that have CPI approved for the indication who have never received CPI or have not had treatment benefit from the last single agent CPI that is approved for the indication or in combination with standard of care therapy
    Exception: gastric/GEJ, esophageal cancer and TNBC may enter if never received CPI.
    E.5 End points
    E.5.1Primary end point(s)
    Escalation (Regimen A and B) and Phase 1 Expansion Regimen B:
    • Incidence of DLTs, AEs, and SAEs overall, by severity, by relationship to each study drug, and those that led to discontinuation of study drug(s)
    • Number and frequency of clinically significant laboratory, electrocardiogram, and vital sign abnormalities
    • Plasma concentrations and PK parameters of GB1275 and metabolites as appropriate

    Escalation (Regimen C):
    • Incidence of DLTs, AEs, and SAEs overall, by severity, by relationship to each study drug, and those that led to discontinuation of study drug(s)
    • Number and frequency of clinically significant laboratory, electrocardiogram, and vital sign abnormalities

    Basket (Cohort 1):
    • Objective response rate (ORR) defined as the proportion of subjects with best overall confirmed response (BOCR) of either a complete response (CR) or partial response (PR) as assessed by the Investigator based on response evaluation criteria in solid tumors (RECIST) v1.1

    Expansion (Cohort 2):
    • ORR defined as the proportion of subjects with BOCR of either a CR or PR as assessed by the Investigator based on RECIST v1.1

    Basket (Cohort 3)
    • ORR defined as the proportion of subjects with BOCR of either a CR or PR as assessed by the Investigator in the Efficacy Evaluable Population


    E.5.1.1Timepoint(s) of evaluation of this end point
    Data/samples collected at screening, day 1,2,8 and 15 of Cycle 1 and day one of every other cycle.
    SAE collection will start after the consent.
    ECG will be collected predose and postdose (2 and/or 6 h)
    E.5.2Secondary end point(s)
    Escalation (Regimen C):
    • Plasma concentrations and PK parameters of GB1275 and metabolites as appropriate
    • Plasma concentrations and PK parameters of gemcitabine (and metabolite
    difluorodeoxyuridine) and nab-paclitaxel (total and free) with and without GB1275

    Basket:
    •DOR
    • TTR
    • CBR
    • PFS
    • TTP
    • OS
    • Incidence of AEs, and SAEs overall, by severity, by relationship to each study drug, and those that led to discontinuation of study drug(s)
    • Number and frequency of clinically significant laboratory, electrocardiogram, and vital sign abnormalities
    • Plasma concentrations of GB1275 and metabolites as appropriate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data/samples collected at screening, day 1,2,8 and 15 of Cycle 1 and day one of every other cycle.
    SAE collection will start after the consent.
    ECG will be collected predose and postdose (2 and/or 6 h)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 242
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legally authorized representative may sign on the subjects behalf if the subject is unable to consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 242
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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