Clinical trials: G12D Mutated KRAS
Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with…
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
- Trial name
- NCT06162221
- Testing
- RMC-6291, RMC-6236, Pembrolizumab
- Where
- 98 sites in United States, Australia and 11 more
- Volunteers
- 616 people
- Sponsor
- Revolution Medicines, Inc.
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Trial name
- NCT07624214
- Testing
- LT-010391
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Advanced KRAS G12D Mutant Solid Tumors
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation.
- Trial name
- NCT06385678
- Testing
- HRS-4642, Adebrelimab, SHR-9839
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Solid Tumor, Advanced Solid Tumor
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer
- Trial name
- NCT05737706
- Testing
- MRTX1133
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- Mirati Therapeutics Inc.
Non-Small Cell Lung Cancer
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer
- Trial name
- TARGET-D 202 (NCT07659782)
- Testing
- VS-7375
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 105 people
- Sponsor
- Verastem, Inc.
Solid Tumor
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation.
- Trial name
- NCT06949761
- Testing
- QLC1101+QL1203, QLC1101+QL2107, QLC1101+QL1706
- Volunteers
- 240 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Pancreatic Cancer, Metastatic Pancreatic Cancer
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic).
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- Trial name
- NCT07409272
- Testing
- Setidegrasib, Oxaliplatin, Leucovorin
- Where
- 79 sites in United States, China and 4 more
- Volunteers
- 614 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pancreatic Cancer, Pancreatic Cancer Metastatic
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- RASolute 309 (NCT07805954)
- Testing
- daraxonrasib, gemcitabine, nab-paclitaxel
- Where
- 5 sites in United States
- Volunteers
- 400 people
- Sponsor
- Revolution Medicines, Inc.
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- MOONRAY-01 (NCT06586515)
- Testing
- LY3962673, Cetuximab, Gemcitabine
- Where
- 52 sites in United States, Canada and 7 more
- Volunteers
- 630 people
- Sponsor
- Eli Lilly and Company
KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
- Trial name
- NCT07232875
- Testing
- HRS-4642 + AG
- Where
- China
- Volunteers
- 588 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer
- Trial name
- NCT07644559
- Testing
- VS-7375, cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 185 people
- Sponsor
- Verastem, Inc.
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
Solid Tumor
A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral…
- Trial name
- NCT06797336
- Testing
- PT0253, Chemotherapy Combination 1, Chemotherapy Combination 2
- Where
- 15 sites in United States, South Korea
- Volunteers
- 300 people
- Sponsor
- PAQ Therapeutics, Inc.
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Trial name
- NCT06040541
- Testing
- RMC-9805, RMC-6236
- Where
- 17 sites in United States
- Volunteers
- 604 people
- Sponsor
- Revolution Medicines, Inc.
Solid Tumors, Adult
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.
- Trial name
- NCT07417189
- Testing
- ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE), ABSK141-800mg
- Where
- China
- Volunteers
- 401 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Advanced Solid Tumor
QTX3046 in Patients With KRAS G12D Mutations
Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
- Trial name
- NCT06428500
- Testing
- QTX3046, Cetuximab
- Where
- 5 sites in United States
- Volunteers
- 240 people
- Sponsor
- Quanta Therapeutics
Metastatic Pancreatic Cancer
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation.
- Trial name
- NCT07262567
- Testing
- GFH375, Chemotherapy
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
Carcinoma, Pancreatic Ductal, Colorectal Neoplasms
A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.
- Conditions
- Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT06447662
- Testing
- PF-07934040, Gemcitabine, Nab-paclitaxel
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 64 people
- Sponsor
- Pfizer
KRAS G12D, T Cell Therapy
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors
At present, there is an urgent need for new drugs for KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002.
- Trial name
- NCT06546150
- Testing
- RE002 T cell
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Henan Cancer Hospital
Pancreatic Ductal Adenocarcinoma, KRAS G12D
Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma
This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P])…
- Conditions
- Pancreatic Ductal Adenocarcinoma, KRAS G12D, KRAS G12V, KRAS G12S
- Trial name
- AMPLIFY-EAP (NCT07083479)
- Testing
- ELI-002 7P
- Sponsor
- Elicio Therapeutics