Clinical trials: G12D Mutated KRAS
Solid Tumor
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with…
- Trial name
- NCT06619587
- Testing
- Phase I Arm A, Phase I Arm B
- Where
- 49 sites in United States, Australia and 10 more
- Volunteers
- 410 people
- Sponsor
- Genentech, Inc.
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.
Solid Tumors
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
- Trial name
- DAWN-303 (NCT07522073)
- Testing
- INCB161734, Investigator's choice of chemotherapy
- Where
- 230 sites in United States, Australia and 20 more
- Volunteers
- 588 people
- Sponsor
- Incyte Corporation
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.
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 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
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
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
Pancreatic Cancer, Pancreatic Cancer Metastatic
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
- Conditions
- Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- RASolute 305 (NCT07621718)
- Testing
- Zoldonrasib, Oxaliplatin, Leucovorin (Calcium Folinate)
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 670 people
- Sponsor
- Revolution Medicines, Inc.
Advanced Solid Tumors
A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
- Trial name
- NCT06963398
- Testing
- HS-10529
- Volunteers
- 520 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Metastatic Pancreatic Cancer
A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
This is a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.
- Trial name
- NCT07026916
- Testing
- GFH375
- Sponsor
- Genfleet Therapeutics (Shanghai) 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
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)
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
Non-small Cell Lung Cancer, Colorectal Cancer
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors
QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration.
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor
- Trial name
- NCT06403735
- Testing
- QLC1101
- Where
- 5 sites in China
- Volunteers
- 250 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Colorectal Cancer, CRC
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.
- Conditions
- Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC
- Trial name
- NCT06445062
- Testing
- RMC-6236, mFOLFOX6 regimen, bevacizumab
- Where
- 32 sites in United States
- Volunteers
- 1,130 people
- Sponsor
- Revolution Medicines, 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
Metastatic Pancreatic Ductal Adenocarcinoma
Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
- Trial name
- NCT07640295
- Testing
- JAB-23E73 tablet，nab-paclitaxel，gemcitabine
- Where
- 13 sites in China
- Volunteers
- 80 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
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
Non-small Cell Lung Cancer (NSCLC)
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells.
- Trial name
- NCT07566052
- Testing
- Setidegrasib, Docetaxel
- Where
- 23 sites in United States, China and 1 more
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.