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    Summary
    EudraCT Number:2020-004721-23
    Sponsor's Protocol Code Number:20190135
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-14
    Trial 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 number2020-004721-23
    A.3Full title of the trial
    A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib (AMG 510) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Master Protocol of Sotorasib (AMG 510) in Subjects with Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
    A.3.2Name or abbreviated title of the trial where available
    Master Protocol of Sotorasib (AMG 510) in Subjects with Advanced Solid Tumors With KRAS p.G12C
    A.4.1Sponsor's protocol code number20190135
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04185883
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Nederland
    B.5.2Functional name of contact pointMedical Information the Netherlands
    B.5.3 Address:
    B.5.3.1Street AddressMinervum 7061
    B.5.3.2Town/ cityBreda
    B.5.3.3Post code4800 DH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310765732500
    B.5.5Fax number+310765732838
    B.5.6E-mailcrsnl@amgen.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 Yes
    D.2.1.1.1Trade name LUMYKRAS
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe 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 nameAMG 510
    D.3.2Product code AMG 510
    D.3.4Pharmaceutical form Film-coated 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 INNSotorasib
    D.3.9.3Other descriptive nameAMG 510
    D.3.9.4EV Substance CodeSUB197397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Vectibix 20mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 namePanitumumab
    D.3.2Product code AMG 954
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.2Current sponsor codeAMG 954
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    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 Yes
    D.3.11.13.1Other medicinal product typeFully human IgG2 monoclonal antibody
    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
    Advanced Solid Tumors with KRAS p.G12C Mutation
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors with KRAS p.G12C Mutation
    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
    All subprotocols
    Phase 1
    To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors
    E.2.2Secondary objectives of the trial
    All subprotocols
    Phase 1
    To characterize PK of product(s) used in investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.
    To evaluate anti-tumor activity of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the full list of inclusion criteria please refer to section 5.1 of the subprotocols.

    All subprotocols
    Pathologically documented, metastatic colorectal cancer / metastatic pancreatic cancer with KRAS p.G12C mutation identified through molecular testing. KRAS p.G12C mutation must be identified by an approved diagnostic device for detection of KRAS p.G12C in NSCLC or be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
    Measurable disease per RECIST 1.1 criteria (Section 11.8)
    Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
    Life expectancy of > 3 months, in the opinion of the investigator
    Ability to take oral medications and willing to record daily adherence to investigational product
    Corrected QT interval (QTc) ≤ 470 msec for women and ≤ 450 msec for men (based on average of screening triplicates
    Adequate hematological laboratory assessments, as follows:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL
    Adequate renal laboratory assessments, as follows:
    • Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 60 ml/min/1.73 m2
    E.4Principal exclusion criteria
    For the full list of exclusion criteria please refer to section 5.2 of the subprotocols.

    All sub protocols
    •History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years
    History of other malignancy within the past 2 years, with the following exceptions:
    •Malignancy treated with curative intent and with no known active disease present for >2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    •Adequately treated cervical carcinoma in situ without evidence of disease.
    •Adequately treated breast ductal carcinoma in situ without evidence of disease.
    •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    •Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
    •Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrythmia requiring medication
    GI tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, uncontrolled inflammatory GI disease (eg, Crohn’s disease, ulcerative colitis)
    •Exclusion of hepatitis infection based on the following results and/or criteria:
    •Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis B)
    •Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody [anti-HBs] testing is necessary. Undetectable anti-HBs in this setting would suggest unclear and possible infection and needs exclusion).
    •Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction (PCR) is necessary. Detectable Hepatitis C virus RNA suggests chronic hepatitis C
    •Known positive test for HIV
    •Has an active infection requiring systemic therapy
    •Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of trial treatment

    E.5 End points
    E.5.1Primary end point(s)
    Dose-limiting toxicities, treatment-emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis for this study will occur when target enrollment is complete and each subject either completes at least 6 months on study or withdraws from the study.
    The final analysis will be conducted and reported following the end of the study. The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long‑term follow‑up), as applicable.
    E.5.2Secondary end point(s)
    Pharmacokinetic parameters of product(s) including, but not limited to, maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), and area under the plasma concentration-time curve (AUC)
    Objective response (complete response[CR] + partial response [PR]), Disease control rate, duration of response, and progression-free survival, measured by computed tomography (CT) or magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis for this study will occur when target enrollment is complete and each subject either completes at least 6 months on study or withdraws from the study.
    The final analysis will be conducted and reported following the end of the study. The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long‑term follow‑up), as applicable.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase Ib Safety, tolerability, PK, PD and efficacy - dose exploration and dose expansion
    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.8.2.4Number of treatment arms in the trial18
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Singapore
    Taiwan
    Australia
    Canada
    Japan
    Korea, Republic of
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (i.e., last subject last visit), including any additional parts in the study (e.g., long-term follow-up [LTFU],), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days9
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 1200
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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