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BI 1701963

DRUG6 trials

Sponsors

Boehringer Ingelheim, Amgen, Mirati Therapeutics Inc.

Conditions

Advanced CancerAdvanced Solid TumorsKirsten Rat Sarcoma (KRAS) pG12C MutationMalignant Neoplasm of ColonMalignant Neoplasm of LungMalignant Neoplastic DiseaseMetastatic CancerMetastatic Colorectal Cancer (CRC)

Phase 1

A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
Active, not recruitingNCT04111458
Boehringer IngelheimSolid Tumors, KRAS Mutation; SOS1
Start: 2019-11-04End: 2027-12-31Updated: 2026-01-12
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Active, not recruitingNCT04185883
AmgenAdvanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Start: 2019-12-17End: 2027-12-05Updated: 2025-10-22
A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation
TerminatedNCT04627142
Boehringer IngelheimMetastatic Colorectal Cancer (CRC)
Start: 2020-11-23End: 2022-01-18Updated: 2022-04-20
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS])
TerminatedNCT04835714
Boehringer IngelheimSolid Tumors, KRAS Mutation
Start: 2021-04-20End: 2022-01-18Updated: 2023-02-01
A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation
Active, not recruitingNCT04973163
Boehringer IngelheimSolid Tumors, KRAS Mutation
Start: 2021-09-09End: 2026-12-27Updated: 2026-02-17
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
TerminatedNCT04975256
Mirati Therapeutics Inc.Advanced Cancer, Malignant Neoplasm of Colon, Malignant Neoplasm of Lung +2
Start: 2021-07-28End: 2022-11-15Updated: 2024-12-16

Related Papers

Abstract 2929: Immune and pharmacodynamic effects of sotorasib plus panitumumab in <i>KRAS</i> G12C-mutant colorectal cancer: Paired biopsy results from CodeBreaK 101.
Cancer Research2026-04-03
Long-term safety and efficacy of sotorasib plus panitumumab and FOLFIRI for previously treated <i>KRAS</i> G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 (phase 1b).
Journal of Clinical Oncology2025-05-284 citations
A phase 3 study of first-line sotorasib, panitumumab, and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb for patients with <i>KRAS</i> G12C–mutated metastatic colorectal cancer (CodeBreaK 301).
Journal of Clinical Oncology2025-01-272 citations
Pooled safety analysis and management of sotorasib-related adverse events in <i>KRAS</i> G12C-mutated advanced non-small cell lung cancer
The Oncologist2025-01-012 citations
Sotorasib plus carboplatin and pemetrexed in <i>KRAS</i> G12C advanced NSCLC: Updated analysis from the international CodeBreaK 101 trial.
Journal of Clinical Oncology2024-06-0115 citations
Sotorasib plus panitumumab for pre-treated non-small cell lung cancer with <i>KRAS</i>G12C mutation: A phase 1b study.
Journal of Clinical Oncology2024-06-011 citations
A phase 1b study of sotorasib combined with panitumumab as second-line treatment of <i>KRAS</i> G12C<i>-</i>mutated colorectal cancer.
Journal of Clinical Oncology2024-01-203 citations
Sotorasib with panitumumab in chemotherapy-refractory KRAS&lt;sup&gt;G12C&lt;/sup&gt;-mutated colorectal cancer: a phase 1b trial.
2024-01-0465 citations
Sotorasib (Soto) plus panitumumab (Pmab) and FOLFIRI for previously treated <i>KRAS </i>G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 phase 1b safety and efficacy.
Journal of Clinical Oncology2023-06-0118 citations
Abstract 2667: Trial in progress: Phase 1 study of BI 1823911, an irreversible KRASG12C inhibitor targeting KRAS in its GDP-loaded state, as monotherapy and in combination with the pan-KRAS SOS1 inhibitor BI 1701963 in solid tumors expressing KRASG12C mutation
Cancer Research2022-06-1515 citations
A phase 1b study of sotorasib, a specific and irreversible KRAS<sup>G12C </sup>inhibitor, in combination with other anticancer therapies in advanced colorectal cancer (CRC) and other solid tumors (CodeBreaK 101).
Journal of Clinical Oncology2022-01-1914 citations
Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRAS<sup>G12C</sup> inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Journal of Clinical Oncology2021-05-2010 citations
A phase I, open-label, dose-escalation trial of BI 1701963 as monotherapy and in combination with trametinib in patients with KRAS mutated advanced or metastatic solid tumors.
Journal of Clinical Oncology2020-05-2036 citations
Trial in progress: A phase Ib study of AMG 510, a specific and irreversible KRAS<sup>G12C</sup> inhibitor, in combination with other anticancer therapies in patients with advanced solid tumors harboring <i>KRAS</i> p.G12C mutation (CodeBreak 101).
Journal of Clinical Oncology2020-05-209 citations