Clinical trials: KRAS G12D
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 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
Pancreatic Cancer, Colorectal Cancer
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal…
- Trial name
- NCT06487377
- Testing
- IX001 TCR-T cells
- Where
- China
- Sponsor
- Shanghai Pudong Hospital
Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways.
- Conditions
- Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous Malformation
- Trial name
- TARGET-VM (NCT05983159)
- Testing
- Alpelisib, Mirdametinib
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Murdoch Childrens Research Institute
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.
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.
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
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, Histiocytic Neoplasm
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer…
- Conditions
- Non-small Cell Lung Cancer, Histiocytic Neoplasm, Histiocytosis, BRAF Gene Mutation
- Trial name
- NCT05786924
- Testing
- S241656, FOLFOX6/FOLFOX7, FOLFIRI
- Where
- 49 sites in United States, Australia and 8 more
- Volunteers
- 554 people
- Sponsor
- Institut de Recherches Internationales Servier
Colorectal Cancer, Lung Cancer
A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors
This is a Phase 1/2, open-label, single-arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of DCTY1102 Injection in participants with advanced malignant tumors harboring…
- Conditions
- Colorectal Cancer, Lung Cancer, Pancreatic Cancer
- Trial name
- NCT07014878
- Testing
- TCR-T cells
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- Beijing DCTY Biotech 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.
Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic…
- Trial name
- NCT07859085
- Testing
- GDC-7035, Panitumumab, mFOLFOX6
- Volunteers
- 388 people
- Sponsor
- Genentech, Inc.
Borderline Resectable Pancreatic Adenocarcinoma
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and…
- Trial name
- NCT07240766
- Testing
- HRS-4642+AG+Nimotuzumab
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Zhejiang University
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.
Advanced Solid Tumor, Pancreatic Adenocarcinoma
A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy or in…
- Conditions
- Advanced Solid Tumor, Pancreatic Adenocarcinoma, Malignant Melanoma (Cutaneous), Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT05585320
- Testing
- IMM-1-104 Monotherapy (Treatment Group A), IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B), IMM-1-104 + modified FOLFIRINOX (Treatment Group C)
- Where
- 20 sites in United States
- Volunteers
- 209 people
- Sponsor
- Immuneering Corporation
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.
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.
KRAS G12D, T Cell Therapy
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors
At present, there is an urgent need for new drugs for KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002.
- Trial name
- NCT06546150
- Testing
- RE002 T cell
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Henan Cancer Hospital
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.
Tumor, Solid
NW-301 TCR-T in Patients With Advanced Solid Tumor
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor
- Trial name
- NCT06956261
- Testing
- NW-301V, Drug: NW-301D
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Peking University