Master Protocol of Sotorasib (AMG 510) in Subjects with Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Phase 1

• Conditions: Advanced Solid Tumors with KRAS p.G12C Mutation; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004721-23-NL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-14
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified