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A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

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Trial Profile

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs Batoprotafib (Primary) ; BI 1701963 (Primary) ; Panitumumab (Primary) ; Sotorasib (Primary) ; Vociprotafib (Primary) ; Zeluvalimab (Primary) ; Afatinib; Atezolizumab; Bevacizumab; Carboplatin; Docetaxel; Everolimus; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin; Paclitaxel; Palbociclib; Pembrolizumab; Pemetrexed; Trametinib
  • Indications Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions
  • Acronyms CodeBreak 101; CodeBreaK 101c
  • Sponsors Amgen

Most Recent Events

  • 27 Mar 2025 Planned primary completion date changed from 29 Apr 2026 to 16 Jun 2026.
  • 06 Mar 2025 Planned End Date changed from 13 Mar 2028 to 5 Dec 2027.
  • 17 Oct 2024 Planned End Date changed from 29 Jun 2029 to 13 Mar 2028.

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