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    Summary
    EudraCT Number:2019-000999-42
    Sponsor's Protocol Code Number:CTMX-M-072-002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-08-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-000999-42
    A.3Full title of the trial
    A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody™ Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
    (PROCLAIM-CX-072-002)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of CX-072 in Combination with other Anticancer Therapy in Adults with Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    PROCLAIM -CX-072-002
    A.4.1Sponsor's protocol code numberCTMX-M-072-002
    A.5.4Other Identifiers
    Name:INDNumber: 142922
    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 SponsorCytomX Therapeutics, 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 supportCytomX Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytomX Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Team
    B.5.3 Address:
    B.5.3.1Street Address151 Oyster Point Boulevard, Suite 400
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post code CA 94080-1913
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650736 9501
    B.5.5Fax number+1650745 4024
    B.5.6E-mailClinicaltrials@cytomx.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCX-072
    D.3.2Product code CX-072
    D.3.4Pharmaceutical form Concentrate for 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 INNnot yet available
    D.3.9.2Current sponsor codeCX-072
    D.3.9.3Other descriptive nameCX-072
    D.3.9.4EV Substance CodeSUB184393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameYervoy
    D.3.4Pharmaceutical form Concentrate for 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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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.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
    Treatment of solid tumors, including advanced/unresectable or metastatic cancer and neoadjuvant/resectable
    E.1.1.1Medical condition in easily understood language
    Treatment of cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term Cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    • To obtain evidence of antitumor effect of CX-072 in combination with ipilimumab in subjects with solid tumors based on the objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
    Part B:
    • To obtain evidence of antitumor effect of CX-072 in combination with ipilimumab in subjects with solid tumors based on pathologic response following neoadjuvant administration of combination treatment
    E.2.2Secondary objectives of the trial
    Part A:
    • Safety and tolerability of CX-072 in combination with ipilimumab in subjects with solid tumors
    • Evaluate antitumor activity in subjects with solid tumors treated with CX-072 in combination with ipilimumab
    • Characterize the pharmacokinetics (PK) of CX-072 and ipilimumab
    • Characterize the incidence of CX-072 antidrug antibodies (ADAs) and ipilimumab ADAs
    Part B:
    • Safety and tolerability of CX-072 in combination with ipilimumab in subjects with solid tumors
    • Evaluate antitumor activity in subjects with solid tumors treated with CX-072 in combination with ipilimumab
    • Characterize the PK profile of CX-072 and ipilimumab
    • Characterize the incidence of CX-072 ADAs and ipilimumab ADAs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age
    2. Measurable disease as defined by RECIST v1.1
    3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
    4. Agree to provide tumor tissue and blood samples for biomarker assessment
    • Part A: Must agree to provide mandatory archival tumor tissue (formalin-fixed paraffin embedded tumor block or unstained slides) or undergo a new tumor biopsy
    • Part B: Must agree to provide tumor tissue from the initial diagnostic biopsy and prospectively agree to provide tumor tissue obtained from surgery on study for pathologic analysis and for biomarker assessment
    5. Subjects with treated brain metastases are eligible if the brain metastases are stable (no magnetic resonance imaging [MRI] evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study treatment) and the subject does not require radiation therapy or steroids. Active screening for brain metastases (eg, brain computed tomography [CT] or MRI) is not required
    6. Screening laboratory values must meet all of the following criteria:
    • White blood cells >2000/µL or 2.0 × 10 to the power of 9/L
    • Neutrophils ≥1500/µL or 1.5 × 10 to the power of 9/L
    • Platelets ≥100 × 10 to the power of 3/µL or 100 × 10 to the power of 9/L
    • Hemoglobin ≥9.0 g/dL (may have been transfused) or 90.0 g/L
    • Creatinine ≤2 mg/dL or 176.8 µmol/L OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine clearance) >50 mL/min
    • AST and ALT ≤2.5 × upper limit of normal (ULN)
    • Total bilirubin within ULN (unless diagnosed with Gilbert’s syndrome, those subjects must have a total bilirubin <3.0 mg/dL or 51.3 µmol/L)
    • Amylase and lipase ≤1.5 × ULN
    • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless subject is on therapeutic anticoagulation, at which time the INR and aPTT must be in the target therapeutic anticoagulation range)
    • Serum albumin ≥2.5 g/dL
    7. Females of childbearing potential and nonsterile males must agree to practice highly effective methods of birth control (as described in Appendix C) for the duration of the study and for 6 months after the last dose of study treatment
    8. The ability to understand and the willingness to sign a written ICF and adhere to study schedule and prohibitions
    See additional cohort-specific inclusion criteria in Sections 4.2, 4.3, 4.4, and 4.5 of the Protocol.
    E.4Principal exclusion criteria
    1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study tr. This interval can be reduced to 2 weeks for subjects who received bone-only radiation therapy or for subjects whose most recent prior therapy was a single-agent, small-molecule kinase inhibitor having a half-life of 3 days or less.
    - For Cohort A2: Prior anti-PD-1/PD-L1 antibody given as a single agent is not excluded within the 28 days prior to the first dose of study treatment. Time from last dose of prior anti-PD-1/PD-L1 inhibitor to first dose of study treatment must be at least the same length as the time interval of the prior PD-1/PD-L1 dosing schedule (eg, if prior PD-1/PD-L1 dosing was once every 14 days, then the last dose must have been at least 14 days prior to first dose of study tr)
    2. Prior therapy with a chimeric antigen receptor T cell–containing regimen
    3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
    4. History of myocarditis regardless of the cause
    5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
    6. History of toxic epidermal necrolysis or Stevens-Johnson syndrome
    7. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications. However, subjects who required brief courses of steroids (eg, as prophylaxis for IV contrastor for treatment of an allergic reaction) may be eligible with Sponsor approval. Inhaled or topical steroids are permitted.
    8. Baseline corrected QT interval (QTc) >470 ms. If a subject starts on a QTc prolonging drug(s), a series of electrocardiograms (ECGs) should be obtained to redefine the baseline QTc.
    9. Unresolved acute toxicity CTCAE v5.0 Grade ≥1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other nonacute toxicities are acceptable.
    10. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
    11. Subjects with known human immunodeficiency virus, acquired immune deficiency syndrome, or any related illness
    12. Subjects with acute or chronic hepatitis B or C
    13. History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant
    14. Major surgery (eg, that required general anesthesia) within 4 weeks prior to the first dose of study treatment (and must be confirmed to be completely healed), or minor surgery (eg, not
    involving chest, abdomen, or intracranial structures) or gamma knife treatment (with adequate healing) within 14 days prior to first dose of study treatment (excluding biopsies conducted with local/topical anesthesia) if complete healing is confirmed
    15. History of active malignancy not related to the cancer being treated within the previous 2 years, with the exception of localized cancers that are considered cured and, in the opinion of the Investigator, present a low risk for recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the prostate, cervix, or breast.
    16. Received a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.
    17. Intercurrent illness including, but not limited to:
    • Ongoing severe aortic stenosis
    • Myocardial infarction or stroke within 24 weeks prior to first dose of study treatment
    • Any of the following within 12 weeks prior to first dose of study treatment: symptomatic congestive heart failure (ie, New York Heart Association Class III or IV), unstable angina pectoris, or clinically significant and uncontrolled cardiac arrhythmia
    • Nonhealing wound or ulcer within 4 weeks prior to Cycle 1 Day 1
    • Active infection requiring systemic antiviral, antibiotic, or antifungal therapy within 5 days prior to first dose of study treatment
    18. Pleural or pericardial effusion or ascites requiring drainage ≥1 time(s) per month
    19. History of multiple myeloma
    20. Women who are pregnant or breastfeeding
    21. Any condition, in the Investigator’s opinion, that would limit the subject’s compliance with study requirements
    22. Participating in an ongoing interventional clinical study (eg, medication, radiation, procedures) unless the subject is only being followed for long-term outcomes
    See additional cohort-specific exclusion criteria in Sections 4.7 and 4.8 of the Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as defined in the Common Core Protocol (Appendix A)
    - Pathologic response following neoadjuvant administration of combination treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    PART A: Radiographic Tumor Assessment and Tumor Response Evaluation : At screening and Scan q8w (±1w) for 12 months and q12w (±1w) thereafter until confirmed progression as assessed by irRECIST
    PART B: Pathologic Response Assessment: Study day 43

    E.5.2Secondary end point(s)
    PART A:
    - Adverse Event Assessment
    - Objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
    - Duration of response (DOR)
    - Time to response (TTR)
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - PK
    - CX-072 antidrug antibodies (ADAs) and ipilimumab ADAs

    PART B:
    - Adverse Event Assessment
    - Objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 prior to surgery
    - Relapse-free survival (RFS)
    - PK
    - CX-072 antidrug antibodies (ADAs) and ipilimumab ADAs
    E.5.2.1Timepoint(s) of evaluation of this end point
    PART A:
    - Radiographic Tumor Assessment and Tumor Response Evaluation : At screening and Scan q8w (±1w) for 12 months and q12w (±1w) thereafter until confirmed progression as assessed by irRECIST
    - CX-072 ADAs: Study day 1, 22, 64, 85, 127, then q42d, Last Tx Day +30d (-2/+7d), Last Tx Day +90d then q90d (±14d)
    - Ipilimumab ADAs: Study day 1, 64
    PART B:
    - Radiographic Tumor Assessment and Tumor Response Evaluation : At screening, study day 40, Scan q12w (±1w) until relapse
    - CX-072 ADAs: Study day 1, 22, 85, 106, 127, 155, 183, then q14d, Last Tx Day +30d (-2/+7d), Last Tx Day +90d then q90d (±14d)
    - Ipilimumab ADAs: Study day 1, 106
    PART A & B:
    - Adverse Event Assessment per Protocol
    - Collect PK samples as shown in Table 3 of Protocol
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.1.1First administration to humans No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    nonsterile males using contraception
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 170
    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 Decision2019-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-21
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