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Trial Summary

Evaluate the safety and tolerability of AMG 510 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.

Acronym:

CodeBreak 100

ACTRN/NCT /ethics:

NCT03600883

Scientific title:

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced Solid Tumors

Sponsor / Cooperative group:

Amgen

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I; Phase II
Age Range18 years and older
SexBoth
Tumour Stream Advanced Solid Tumors
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2018-08-27
Anticipated End Date2024-03-08

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6410
Principal InvestigatorProfessor Tim Price
Recruitment StatusRecruiting