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TNO155

DRUG11 trials

Sponsors

Novartis Pharma AG, Novartis Pharmaceuticals, Amgen, Massachusetts General Hospital, Mirati Therapeutics Inc.

Conditions

Advance solid tumors harboring the KRAS G12C mutationAdvanced CancerAdvanced EGFR Mutant Non Small Cell LungCancer (NSCLC)Advanced Gastrointestinal Stromal Tumors (GIST)Advanced NRAS/BRAFT wt Cutaneous MelanomaAdvanced Solid TumorsAdvanced Solid Tumors Harboring the KRAS G12C MutationAnaplastic Lymphoma Kinase Gene Translocation

Phase 1

Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
TerminatedNCT03114319
Novartis PharmaceuticalsAdvanced EGFR Mutant Non Small Cell LungCancer (NSCLC), Advanced Gastrointestinal Stromal Tumors (GIST), Advanced NRAS/BRAFT wt Cutaneous Melanoma +4
Start: 2017-05-26End: 2025-07-04Updated: 2025-08-28
Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
TerminatedNCT04000529
Novartis PharmaceuticalsColorectal Cancer, Esophageal SCC, Gastrointestinal Stromal Tumors +2
Start: 2019-07-30End: 2024-01-15Updated: 2025-09-30
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
Lorlatinib Combinations in Lung Cancer
NCT04292119
Massachusetts General HospitalAnaplastic Lymphoma Kinase Gene Translocation, Lung Cancer, MET Amplification +4
Start: 2020-05-01End: 2023-03-01Target: 96Updated: 2021-03-10
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
TerminatedNCT04294160
Novartis PharmaceuticalsBRAF V600 Colorectal Cancer
Start: 2020-07-22End: 2024-09-25Updated: 2025-12-24
Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)
CompletedNCT04330664
Mirati Therapeutics Inc.Advanced Cancer, Malignant Neoplastic Disease, Metastatic Cancer
Start: 2020-04-07End: 2025-02-24Updated: 2025-04-04
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Active, not recruitingNCT04699188
Novartis PharmaceuticalsCancer of Lung, Cancer of the Lung, Carcinoma, Colorectal +7
Start: 2021-02-24End: 2027-01-25Updated: 2026-03-18
Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Participants
WithdrawnNCT05490030
Novartis PharmaceuticalsHepatic Impairment
Start: 2025-03-06End: 2025-06-26Updated: 2024-02-29
Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Participants
WithdrawnNCT05541159
Novartis PharmaceuticalsRenal Impairment
Start: 2025-03-19End: 2025-07-15Updated: 2024-02-29
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
Active, not recruitingCTIS2023-508073-87-00
Novartis Pharma AGAdvance solid tumors harboring the KRAS G12C mutation
Start: 2024-11-14Target: 359Updated: 2026-01-16
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Not yet recruitingNCT07468071
Novartis PharmaceuticalsAdvanced Solid Tumors Harboring the KRAS G12C Mutation, Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer
Start: 2026-06-15End: 2029-09-17Target: 40Updated: 2026-04-02

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
Abstract CT073: A first-in-human study of oral TNO155 (batoprotafib) alone and in combination with EGF816 (nazartinib) in adult patients with advanced solid tumors
Cancer Research2025-04-25
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
43O A dose-escalation study of TNO155 (TN) in combination with spartalizumab (SPA) or ribociclib (RIB) in adults with advanced solid tumors
ESMO Open2024-02-01
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
KontRASt-01 update: Safety and efficacy of JDQ443 in <i>KRAS G12C</i>-mutated solid tumors including non-small cell lung cancer (NSCLC).
Journal of Clinical Oncology2023-06-0131 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
A phase II trial of JDQ443 in <i>KRAS G12C</i>-mutated NSCLC with PD-L1 expression &lt;1% or PD-L1 expression ≥1% and an <i>STK11</i> co-mutation.
Journal of Clinical Oncology2023-06-015 citations
Abstract CT048: A Phase II trial of JDQ443 in <i>KRAS G12C-</i>mutated NSCLC with PD-L1 expression &amp;lt;1% or PD-L1 expression≥1% and an <i>STK11</i> co-mutation
Cancer Research2023-04-14
Phase 1 Study of Ceritinib Combined With Trametinib in Patients With Advanced ALK- or ROS1-Positive NSCLC.
2022-11-216 citations
JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRAS<sup>G12C</sup> for the Treatment of Solid Tumors
Journal of Medicinal Chemistry2022-11-1884 citations
Abstract CT033: KontRASt-01: A phase Ib/II, dose-escalation study of JDQ443 in patients (pts) with advanced, KRAS G12C-mutated solid tumors
Cancer Research2022-06-1517 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
Abstract P124: JDQ443, a covalent irreversible inhibitor of KRAS G12C, exhibits a novel binding mode and demonstrates potent anti-tumor activity and favorable pharmacokinetic properties in preclinical models
Molecular Cancer Therapeutics2021-12-0110 citations
Abstract LBA038: KontRASt: A Phase Ib/II, open-label, multi-center, dose-escalation study of JDQ443 in patients with advanced solid tumors harboring the <i>KRAS G12C</i> mutation
Molecular Cancer Therapeutics2021-12-014 citations

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