A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Status and phase
Active, not recruiting
Phase 2
Phase 1
Conditions
KRAS p.G12C Mutant Advanced Solid Tumors
Treatments
Drug: Anti PD-1/L1
Drug: sotorasib
Drug: Midazolam
Details and patient eligibility
About
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Enrollment
713 patients
Sex
All
Ages
18 to 100 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion Criteria
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
713 participants in 6 patient groups
Phase 1 Dose Exploration Part 1 monotherapy
Experimental group
Description:
Cohorts with food effect and alternative dosing regimens
Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
Treatment:
Drug: sotorasib
Phase 1 Dose Expansion Part 2 monotherapy
Experimental group
Description:
Upon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 3 groups may be done concurrently
Treatment:
Drug: sotorasib
Phase 1 combination arm with sotorasib and anti PD-1/L1
Experimental group
Description:
Additional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1)
Treatment:
Drug: sotorasib
Drug: Anti PD-1/L1
Phase 1 monotherapy treatment naive advanced NSCLC
Experimental group
Description:
Separate cohort of part 1 dose expansion subjects to evaluate the safety and clinical activity of sotorasib administered orally once daily in subjects with previously untreated advanced non-small cell lung cancer (NSCLC). Drug-drug interaction will be evaluated in 6 of the subjects enrolled in the treatment naive cohort by adding Midazolam alone on Day -1 and in combination with sotorasib on Day 15 of Cycle 1, where each cycle is 21 days.
Treatment:
Drug: Midazolam
Drug: sotorasib
Phase 2 monotherapy dose comparison
Experimental group
Description:
Subjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy
Treatment:
Drug: sotorasib
Phase 1 Does escalation and Expansion monotherapy BID
Experimental group
Description:
BID 2L+solid tumors (fed state)
Treatment:
Drug: sotorasib
Trial contacts and locations
133
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Data sourced from clinicaltrials.gov
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