Clinical trials: KRAS G12D Mutation
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.
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, 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 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.
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.
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.
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
- 20 sites in United States, France and 2 more
- Volunteers
- 404 people
- Sponsor
- Astellas Pharma Inc
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.
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
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.
Metastatic Pancreatic Carcinoma
HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment…
- Trial name
- NCT06770452
- Testing
- HRS-4642, Nimotuzumab, gemcitabine + nab-paclitaxel
- Where
- 2 sites in China
- Volunteers
- 133 people
- Sponsor
- Zhejiang University
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
Gastrointestinal Carcinoma, Pancreatic Cancer
A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies
Background: Gastrointestinal (GI) cancer affects the organs (such as the stomach, large and small intestine, pancreas, colon, liver, and biliary system) of the digestive tract.
- Conditions
- Gastrointestinal Carcinoma, Pancreatic Cancer, Hepatocellular Cancer, Cholangiocarcinoma
- Trial name
- NCT06690281
- Testing
- KRAS TCR-Transduced PBL, Aldesleukin, Fludarabine
- Where
- United States
- Sponsor
- National Cancer Institute (NCI)
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.
KRAS G12D Mutations, Pancreatic Ductal Adenocarcinoma (PDAC)
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
This is a multicenter, open-label, phase Ⅱa study to explore the safety, tolerability, and preliminary efficacy of RNK08954 in metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation.
- Trial name
- NCT07303465
- Testing
- RNK08954
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Ranok Therapeutics (Hangzhou) 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.
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.
Solid Tumor
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS.
- Trial name
- NCT06364696
- Testing
- ASP4396
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Astellas Pharma 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
KRAS G12D Mutation
A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation
This is a first in human (FIH), Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability and pharmacokinetics of RNK08954 to determine the optimal dose and recommended dose for…
- Trial name
- TRIAD1 (NCT06667544)
- Testing
- RNK08954-01
- Where
- 6 sites in China
- Volunteers
- 152 people
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.