Clinical trials: G12D Mutated KRAS
KRAS G12V, KRAS G12D
TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors
This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.
- Conditions
- KRAS G12V, KRAS G12D, Solid Tumor
- Trial name
- NCT07342738
- Testing
- TCR-T cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Sun Yat-sen University
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.
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 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.
KRAS G12D Mutation, NSCLC (Non-small Cell Lung Cancer)
A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation
The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC).
- Trial name
- NCT07668752
- Testing
- GFH375, Docetaxel
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
Locally Advanced Pancreatic Cancer With KRAS G12D Mutation
A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer
This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer.
- Trial name
- NCT07438106
- Testing
- HRS-4642 Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical 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
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.
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
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.
Gastrointestinal Cancer, Pancreatic Cancer
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients
Background: A new cancer therapy takes white blood cells from a person, grows them in a lab, genetically changes them, then gives them back to the person.
- Conditions
- Gastrointestinal Cancer, Pancreatic Cancer, Gastric Cancer, Colon Cancer
- Trial name
- NCT03745326
- Testing
- Cyclophosphamide, Fludarabine, Aldesleukin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
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.
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.
Solid Tumor, Adult, EphA2 Overexpression
CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide…
- Conditions
- Solid Tumor, Adult, EphA2 Overexpression, KRAS G12V, KRAS G12C
- Trial name
- NCT05631899
- Testing
- KRAS-EphA-2-CAR-DC, Abraxane, Cyclophosphamide
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Chinese PLA General Hospital
Advanced Gynecologic Malignancies
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Advanced Gynecological Tumors.
This is a multicenter, open-label, phase II clinical study to evaluate the safety and preliminary efficacy of RNK08954 in patients with advanced gynecological tumors
- Trial name
- NCT07848893
- Testing
- RNK08954
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Ranok Therapuetics 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.
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 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.
KRAS G12D Mutations, Advanced Solid Tumors
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
- Trial name
- NCT06500676
- Testing
- GFH375
- Where
- 20 sites in China
- Volunteers
- 407 people
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
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.