Clinical trials: KRAS G12D
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
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.
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
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 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
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
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
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 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
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
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.
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.
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.
Non-Small Cell Lung Cancer, NSCLC
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer)
- Trial name
- NCT06917079
- Testing
- BBO-11818, Pembrolizumab, Platinum chemotherapy (cisplatin or carboplatin)
- Where
- 17 sites in United States, Australia
- Volunteers
- 665 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Pancreatic Cancer
Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation
This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation.
- Trial name
- NCT07689539
- Testing
- DN022150, Chemotherapy
- Volunteers
- 360 people
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
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.
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
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.
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.
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