Clinical trials: KRAS G12D Mutation
Pancreatic Cancer
A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy.
- Trial name
- NCT07784374
- Testing
- GFH375, GFH276, GFS202A
- Where
- China
- Volunteers
- 120 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 P.G12D
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants…
- Trial name
- NCT07456046
- Testing
- D3S-003
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 42 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
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.
Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, KRAS G12D, KRAS G12R
- Trial name
- AMPLIFY-7P (NCT05726864)
- Testing
- ELI-002 7P
- Where
- 28 sites in United States
- Volunteers
- 158 people
- Sponsor
- Elicio Therapeutics
Advance Solid Tumors, Colon and Rectal Cancer
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
- Conditions
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC, Pancreatic Adenocarcinoma Advanced or Metastatic
- Trial name
- NCT07610798
- Testing
- INV-8989
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Shenzhen Ionova Life Sciences 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.
Advanced/Metastatic Colorectal Adenocarcinoma
A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation
Researchers are looking for a better way to treat people who have advanced or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS.
- Trial name
- NCT07535112
- Testing
- BAY 3771249, Cetuximab
- Where
- 21 sites in United States, Australia and 8 more
- Volunteers
- 130 people
- Sponsor
- Bayer
Advanced Solid Tumor (Phase 1), Pancreas Adenocarcinoma
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic…
- Conditions
- Advanced Solid Tumor (Phase 1), Pancreas Adenocarcinoma, Non-small Cell Lung Cancer, Malignant Melanoma (Cutaneous)
- Trial name
- NCT06208124
- Testing
- IMM-6-415
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Immuneering Corporation
Advanced KRAS G12D Mutant Solid Tumors
Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
The study is being conducted to evaluate the safety and tolerability of HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum tolerated dose (MTD) and/or a biologically active dose…
- Trial name
- NCT05533463
- Testing
- HRS-4642
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Non-small Cell Lung Cancer, Colorectal Carcinoma
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
- Conditions
- Non-small Cell Lung Cancer, Colorectal Carcinoma, Pancreatic Ductal Adenocarcinoma, Endometrial Cancer
- Trial name
- NCT06218914
- Testing
- NT-112: Autologous, engineered T Cells targeting KRAS G12D, AZD0240: Autologous, engineered T Cells targeting KRAS G12D
- Where
- 18 sites in United States
- Volunteers
- 108 people
- Sponsor
- AstraZeneca
Colorectal Cancer
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer
- Trial name
- TARGET-D 203 (NCT07659795)
- Testing
- VS-7375, cetuximab, panitumumab
- Where
- 30 sites in United States, Australia
- Volunteers
- 150 people
- Sponsor
- Verastem, 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.
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
Advanced Solid Tumors Cancer, PDAC
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To…
- Conditions
- Advanced Solid Tumors Cancer, PDAC, CRC (Colorectal Cancer)
- Trial name
- NCT07259590
- Testing
- GFH375
- Where
- 4 sites in China
- Volunteers
- 126 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
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.
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
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.
Solid Tumor, Non-Small-Cell Lung Cancer
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS.
- Conditions
- Solid Tumor, Non-Small-Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
- Trial name
- NCT07094204
- Testing
- ASP5834, panitumumab
- Where
- 22 sites in United States, France and 3 more
- Volunteers
- 404 people
- Sponsor
- Astellas Pharma Inc
Solid Tumors
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
- Trial name
- NCT06179160
- Testing
- INCB161734, Cetuximab, Retifanlimab
- Where
- 34 sites in United States, Australia and 6 more
- Volunteers
- 710 people
- Sponsor
- Incyte Corporation