Clinical trials: KRAS G12C Mutation
Non-Small Cell Lung Cancer (NSCLC)
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
This study was designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd was evaluated in participants with metastatic or unresectable NSCLC with…
- Trial name
- NCT03260491
- Testing
- HER3-DXd (FL-DP), HER3-DXd (CTM-1 Lyo-DP), HER3-DXd (CTM-3 Lyo-DP)
- Where
- 37 sites in United States, Japan and 4 more
- Volunteers
- 312 people
- Sponsor
- Daiichi Sankyo
Carcinoma, Pancreatic Ductal, Colorectal Neoplasms
A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.
- Conditions
- Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT06447662
- Testing
- PF-07934040, Gemcitabine, Nab-paclitaxel
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 64 people
- Sponsor
- Pfizer
Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation
This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic…
- Trial name
- NCT06416410
- Testing
- JAB-21822, Tislelizumab, JAB-3312
- Where
- 37 sites in China
- Volunteers
- 392 people
- Sponsor
- Allist Pharmaceuticals, Inc.
Advanced Cancer, Metastatic Cancer
Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation.
- Conditions
- Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
- Trial name
- NCT04330664
- Testing
- MRTX849, TNO155
- Where
- 17 sites in United States
- Volunteers
- 86 people
- Sponsor
- Mirati Therapeutics Inc.
Solid Tumor, Adult, NSCLC
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)
This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.
- Conditions
- Solid Tumor, Adult, NSCLC, Advanced Cancer, Metastatic Cancer
- Trial name
- NCT05840510
- Testing
- Adagrasib, nab-Sirolimus
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Mirati Therapeutics Inc.
Advanced Malignant Tumour
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour.
- Trial name
- NCT06383871
- Testing
- HRS-7058 capsule/ HRS-7058 tablet
- Where
- China
- Volunteers
- 233 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Solid Tumor
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS…
- Trial name
- NCT06166836
- Testing
- D1553, IN10018（Ifebemtinib）
- Where
- 10 sites in China
- Volunteers
- 140 people
- Sponsor
- InxMed (Shanghai) Co., Ltd.
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are…
- Trial name
- NCT04613596
- Testing
- Adagrasib, Pembrolizumab
- Where
- 770 sites in United States, Argentina and 45 more
- Volunteers
- 626 people
- Sponsor
- Mirati Therapeutics Inc.
Non-Small Cell Lung Cancer, NSCLC
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer)
- Trial name
- NCT06917079
- Testing
- BBO-11818, Pembrolizumab, Platinum chemotherapy (cisplatin or carboplatin)
- Where
- 17 sites in United States, Australia
- Volunteers
- 665 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Colorectal Cancer
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic…
- Trial name
- NCT05497336
- Testing
- IBI351, Cetuximab
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Solid Tumors
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer…
- Trial name
- NCT07415031
- Testing
- Adagrasib, Pembrolizumab, Cetuximab
- Where
- 101 sites in United States, Australia and 19 more
- Volunteers
- 170 people
- Sponsor
- Mirati Therapeutics Inc.
Advanced Solid Tumors, Colorectal Cancer (CRC)
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368.
- Conditions
- Advanced Solid Tumors, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer, Uterine Cancer
- Trial name
- NCT07542704
- Testing
- KQB368
- Volunteers
- 48 people
- Sponsor
- Kumquat Biosciences Inc.
Neoplasm Malignant
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
- Trial name
- KANDLELIT-014 (NCT07209111)
- Testing
- Calderasib, Cetuximab
- Where
- 72 sites in United States, Australia and 17 more
- Volunteers
- 150 people
- Sponsor
- Merck Sharp & Dohme LLC
KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
The study is being conducted to evaluate the efficacy, and safety of HRS-7058 in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
- Trial name
- NCT07601048
- Testing
- HRS-7058, Fulzerasib Tablets, Garsorasib Tablets
- Where
- China
- Volunteers
- 450 people
- Sponsor
- Shandong Suncadia 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
Advanced Colorectal Cancer, Metastatic Colorectal Cancer
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with…
- Trial name
- NCT04793958
- Testing
- MRTX849, Cetuximab, mFOLFOX6 Regimen
- Where
- 419 sites in United States, Argentina and 30 more
- Volunteers
- 461 people
- Sponsor
- Mirati Therapeutics Inc.
Non-small Cell Lung Cancer
VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
This is a Phase 1a/1b study of aurora kinase A inhibitor VIC-1911 administered as monotherapy and in combination with sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutant non-small cell lung…
- Trial name
- NCT05374538
- Testing
- VIC-1911, sotorasib
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- Vitrac Therapeutics, LLC
KRAS G12C
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
Phase Ia: To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.
- Trial name
- NCT05005234
- Testing
- GFH925
- Where
- China
- Volunteers
- 334 people
- Sponsor
- Innovent Biologics (Suzhou) 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
KRAS P.G12C
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001…
- Trial name
- NCT05410145
- Testing
- D3S-001, Pembrolizumab, Cisplatin
- Where
- 52 sites in United States, Australia and 8 more
- Volunteers
- 442 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd