Clinical trials: KRAS G12D Mutation
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.
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
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 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 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 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.
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 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.
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.
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
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.
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.
Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with…
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
- Trial name
- NCT06162221
- Testing
- RMC-6291, RMC-6236, Pembrolizumab
- Where
- 98 sites in United States, Australia and 11 more
- Volunteers
- 616 people
- Sponsor
- Revolution Medicines, 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 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, Metastatic Pancreatic Cancer
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic).
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- Trial name
- NCT07409272
- Testing
- Setidegrasib, Oxaliplatin, Leucovorin
- Where
- 79 sites in United States, China and 4 more
- Volunteers
- 614 people
- Sponsor
- Astellas Pharma Global Development, 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.
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.
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.