drugset / Trial / NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

NCT04185883 ↗

Phase 1 Active not recruiting 610 enrolled Amgen
Non-randomizedSequentialOpen-labelTreatment

Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Timeline

Start
2019-12-17
Primary completion
2026-12-17
Completion
2027-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject AMG 404 Monoclonal antibody — Intravenous
Subject Afatinib Small molecule — Oral
Subject Atezolizumab Monoclonal antibody — Intravenous
Subject BATOPROTAFIB Small molecule — Oral
Subject BI 1701963 Small molecule — Oral
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Carboplatin Small molecule — Intravenous
Subject Docetaxel Small molecule — Intravenous
Subject Everolimus Small molecule — Oral
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject Paclitaxel Small molecule — —
Subject Palbociclib Small molecule — Oral
Subject Panitumumab Monoclonal antibody — Intravenous
Subject Pembrolizumab Monoclonal antibody — Intravenous
Subject Pemetrexed Small molecule — Intravenous
Subject Sotorasib Small molecule — Oral
Subject Trametinib Small molecule — Oral
Subject Vociprotafib Small molecule — Oral
Subject fluorouracil Small molecule — Intravenous

Indications