Clinical trials: KRAS Mutant Metastatic Colorectal Cancer
Colorectal Cancer, Pancreatic Cancer
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient…
- Trial name
- NCT06411691
- Testing
- KRAS Vaccine with Poly-ICLC adjuvant, Balstilimab, Botensilimab
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or…
- Conditions
- Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8
- Trial name
- NCT03981614
- Testing
- Binimetinib, Palbociclib, Trifluridine and Tipiracil Hydrochloride
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Academic and Community Cancer Research United
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.
- Conditions
- Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer, Advanced Solid Tumors
- Trial name
- NCT07148128
- Testing
- WEF-001
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 110 people
- Sponsor
- Auricula Biosciences Inc.
Solid Tumors for Phase Ib, Pancreatic Cancer for Phase II
Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors
Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.
- Conditions
- Solid Tumors for Phase Ib, Pancreatic Cancer for Phase II, Colorectal Cancer for Phase II
- Trial name
- NCT02703571
- Testing
- ribociclib, Trametinib
- Where
- 15 sites in United States, Australia and 5 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Cancer, Gastrointestinal Neoplasms
A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer
This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal…
- Conditions
- Gastrointestinal Cancer, Gastrointestinal Neoplasms, Colorectal Cancer, Colorectal Neoplasms
- Trial name
- NCT03597581
- Testing
- ompenaclid, FOLFIRI, Bevacizumab
- Where
- 17 sites in United States
- Volunteers
- 89 people
- Sponsor
- Inspirna, Inc.
Colorectal Neoplasms
A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation
The main purpose of this study is to evaluate how well olomorasib is tolerated and what side effects may occur when combined with other interventions in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)…
- Trial name
- NCT07814417
- Testing
- Olomorasib, Cetuximab, Oxaliplatin
- Where
- 18 sites in United States, China and 1 more
- Volunteers
- 50 people
- Sponsor
- Eli Lilly and Company
Colorectal Cancer, Pancreatic Ductal Cancer
A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
The primary objectives of Part 1 of this study are to: Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation…
- Conditions
- Colorectal Cancer, Pancreatic Ductal Cancer, Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
- Trial name
- NCT06194877
- Testing
- BGB-3245, Panitumumab
- Where
- 5 sites in United States, Australia
- Volunteers
- 13 people
- Sponsor
- MapKure, LLC
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor
- Trial name
- NCT06607185
- Testing
- LY4066434., Cetuximab, Nab paclitaxel
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 750 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumor, Non-Small Cell Lung Cancer
A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations
A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or…
- Conditions
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT07629960
- Testing
- BLU-924
- Where
- 16 sites in United States, Spain
- Volunteers
- 265 people
- Sponsor
- Blueprint Medicines Corporation
BRAF NP_004324.2:p.V600X, KRAS wt Allele
Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of vemurafenib when given together with cetuximab and irinotecan hydrochloride in treating patients with solid tumors that have spread to other parts of the body or cannot…
- Conditions
- BRAF NP_004324.2:p.V600X, KRAS wt Allele, Metastatic Malignant Solid Neoplasm, Stage IV Colorectal Cancer AJCC v7
- Trial name
- NCT01787500
- Testing
- Cetuximab, Irinotecan Hydrochloride, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- M.D. Anderson Cancer Center
Colorectal Cancer
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer
- Trial name
- NCT01719380
- Testing
- LGX818, Cetuximab, BYL719
- Where
- 52 sites in United States, Australia and 10 more
- Volunteers
- 156 people
- Sponsor
- Pfizer
Metastatic Colorectal Cancer
QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia.
- Trial name
- NCT00813605
- Testing
- FOLFIRI, AMG 655, AMG 479
- Where
- 67 sites in United States, France and 8 more
- Volunteers
- 155 people
- Sponsor
- NantCell, Inc.
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic…
- Trial name
- NCT06336902
- Testing
- Balstilimab, Biospecimen Collection, Botensilimab
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Southern California
Non-small Cell Lung Cancer, Pancreas Cancer
T Cell Receptor T Cells for Advanced KRAS G12V-mutant Non-small Cell Lung Cancer, Pancreas Cancer, Colon Cancer
This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in…
- Conditions
- Non-small Cell Lung Cancer, Pancreas Cancer, Colon Cancer
- Trial name
- NCT06043713
- Testing
- Bendamustine, Biopsy, Biospecimen Collection
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Fred Hutchinson Cancer Center
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
- Conditions
- Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC (Colorectal Cancer)
- Trial name
- NCT06835569
- Testing
- ALTA3263, cetuximab, mFOLFOX6
- Where
- 14 sites in United States
- Volunteers
- 448 people
- Sponsor
- Alterome Therapeutics, Inc.
Colorectal Cancer
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free…
- Trial name
- NCT01479465
- Testing
- Simtuzumab, Leucovorin, Irinotecan
- Where
- 109 sites in United States, France and 5 more
- Volunteers
- 266 people
- Sponsor
- Gilead Sciences
Colorectal Cancer
Lapatinib Plus Trametinib in KRAS Mutant NSCLC
This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm…
- Trial name
- M14LTK (NCT02230553)
- Testing
- Lapatinib, trametinib
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- The Netherlands Cancer Institute