Clinical trials: KRAS Gene Mutation
Carcinoma, Non-Small-Cell Lung
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with…
- Trial name
- NCT06875310
- Testing
- Adagrasib, Pembrolizumab, Carboplatin
- Where
- 317 sites in United States, Argentina and 33 more
- Volunteers
- 630 people
- Sponsor
- Mirati Therapeutics Inc.
Advance Non-small Cell Lung Cancer
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in…
- Trial name
- NCT05756153
- Testing
- GFH925, Cetuximab
- Where
- 21 sites in Greece, Italy and 1 more
- Volunteers
- 47 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
Pancreatic Cancer, Pancreatic Cancer Metastatic
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- RASolute 303 (NCT07491445)
- Testing
- daraxonrasib, gemcitabine, nab-paclitaxel
- Where
- 82 sites in United States, Australia and 14 more
- Volunteers
- 900 people
- Sponsor
- Revolution Medicines, Inc.
Metastatic Colorectal Cancer
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or…
- Trial name
- CodeBreaK 301 (NCT06252649)
- Testing
- FOLFIRI Regimen, Sotorasib, Panitumumab
- Where
- 291 sites in United States, Argentina and 33 more
- Volunteers
- 450 people
- Sponsor
- Amgen
Solid Tumors
QTX3034 in Patients With KRAS G12D Mutation
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
- Trial name
- NCT06227377
- Testing
- QTX3034, Cetuximab
- Where
- 14 sites in United States
- Volunteers
- 250 people
- Sponsor
- Quanta Therapeutics
Non Small Cell Lung Cancer, KRAS Activating Mutation
Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced…
- Conditions
- Non Small Cell Lung Cancer, KRAS Activating Mutation, Advanced Cancer, Metastatic Cancer
- Trial name
- RAMP204 (NCT05375994)
- Testing
- avutometinib (VS-6766) and adagrasib
- Where
- 8 sites in United States
- Volunteers
- 12 people
- Sponsor
- Verastem, Inc.
Malignant Neoplasm
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors.
- Trial name
- NCT06385925
- Testing
- TSN1611
- Where
- 19 sites in United States, China
- Volunteers
- 440 people
- Sponsor
- Tyligand Pharmaceuticals (Suzhou) Limited
Pancreatic Cancer, PDAC
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
- Conditions
- Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- RASolute 302 (NCT06625320)
- Testing
- RMC-6236, Gemcitabine, nab-paclitaxel
- Where
- 60 sites in United States, France and 5 more
- Volunteers
- 500 people
- Sponsor
- Revolution Medicines, Inc.
KRAS p.G12C Mutant Advanced Solid Tumors
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Evaluate the safety and tolerability of sotorasib 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…
- Trial name
- NCT03600883
- Testing
- sotorasib, Anti PD-1/L1, Midazolam
- Where
- 133 sites in United States, Australia and 14 more
- Volunteers
- 713 people
- Sponsor
- Amgen
KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced…
- Conditions
- KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung
- Trial name
- KontRASt-01 (NCT04699188)
- Testing
- JDQ443, TNO155, tislelizumab
- Where
- 38 sites in United States, Australia and 14 more
- Volunteers
- 344 people
- Sponsor
- Novartis Pharmaceuticals
NSCLC, Non-small Cell Lung Cancer
Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with…
- Conditions
- NSCLC, Non-small Cell Lung Cancer, Non-Small Cell Lung Cancer NSCLC, Non-Squamous Non Small Cell Lung Cancer
- Trial name
- RASolve 308 (NCT07777822)
- Testing
- zoldonrasib, pembrolizumab, pemetrexed + cisplatin /carboplatin
- Where
- United States
- Volunteers
- 430 people
- Sponsor
- Revolution Medicines, Inc.
Colorectal Cancer, Metastatic Colorectal Cancer
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for…
- Trial name
- NCT05593328
- Testing
- Onvansertib, FOLFIRI, Bevacizumab
- Where
- 27 sites in United States
- Volunteers
- 23 people
- Sponsor
- Cardiff Oncology
Solid Tumors
A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.
- Trial name
- NCT06818812
- Testing
- INCB186748, Cetuximab, GEMNabP
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Incyte Corporation
Advanced Solid Tumor, Non-Small Cell Lung Cancer
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.
- Conditions
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT04165031
- Testing
- LY3499446, Abemaciclib, Cetuximab
- Where
- 6 sites in United States, Australia
- Volunteers
- 5 people
- Sponsor
- Eli Lilly and Company
NSCLC
A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.
- Trial name
- NCT00655161
- Testing
- GI-4000
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- GlobeImmune
Advanced Solid Tumors
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 Monotherapy and in Combination with Other Agents in adult participants with advanced solid tumors
- Trial name
- NCT06973564
- Testing
- JAB-23E73, Cetuximab
- Where
- 4 sites in United States
- Volunteers
- 344 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Non Small Cell Lung Cancer, Solid Tumor
SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
- Trial name
- NCT05375084
- Testing
- BBP-398 with nivolumab
- Where
- 15 sites in United States
- Volunteers
- 21 people
- Sponsor
- Navire Pharma Inc., a BridgeBio company
NSCLC
A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
This is a randomized, positive controlled, open-Label and multicenter phase III study, to evaluate the efficacy and safety of Sosimerasib in combination with IN10018 versus anti-PD-1 monoclonal antibody in combination with…
- Trial name
- NCT07833202
- Testing
- Sosimerasib in combination with IN10018, Tislelizumab + Carboplatin + Pemetrexed
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Shanghai Jeyou Pharmaceutical Co., Ltd.
Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.
- Trial name
- NCT04380753
- Testing
- AMG 510
- Where
- 4 sites in Hong Kong, Taiwan
- Volunteers
- 12 people
- Sponsor
- Amgen
NSCLC, Solid Tumor
A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China
To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.
- Trial name
- NCT05009329
- Testing
- JAB-21822
- Where
- China
- Volunteers
- 315 people
- Sponsor
- Allist Pharmaceuticals, Inc.