Cancer
Codebreak 101
A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation
Trial overview
Topic
Basket – Solid Tumours
Description
A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation
Eligibility 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.
- Exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless contraindicated)
- Performance Status ≤ 2
Study details
Primary Objective:
- To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumours.
Secondary Objectives:
- To characterize PK of product(s) used in investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumours.
Further information
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Location