Clinical trials: G12D Mutated KRAS
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
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
NSCLC (Advanced Non-small Cell Lung Cancer)
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer
This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy…
- Trial name
- NCT07554859
- Testing
- ArmA:GFH375, Arm B:GFH375, Arm C:GFH375
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Genfleet Therapeutics (Shanghai) 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, 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.
KRAS G12D Mutation, Advanced Solid Cancer
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
- Trial name
- NCT07023731
- Testing
- ARV-806
- Where
- 14 sites in United States
- Volunteers
- 76 people
- Sponsor
- Arvinas Inc.
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.
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.
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.
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.
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.
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.
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, 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.
Advanced KRAS G12D Mutant Solid Tumors
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors.
- Trial name
- NCT07134998
- Testing
- HRS-6093
- Where
- 2 sites in China
- Volunteers
- 153 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumor
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid…
- Trial name
- NCT06959615
- Testing
- JAB-23E73
- Where
- 32 sites in China
- Volunteers
- 334 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
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
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult
- Trial name
- NCT07020221
- Testing
- VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 616 people
- Sponsor
- Verastem, Inc.
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.
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.