Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Cetuximab

Adagrasib

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Participants assigned to Stage 1, participants dose levels of MRTX849 and irinotecan will depend on when the participants joined the study. This study will also test 2 different dosing schedules: concurrent dosing or staggered dosing

Participants assigned to Stage 2 will receive MRTX849 and irinotecan at the dose level that was recommended during Stage 1. This study will also test 2 different dosing schedules: concurrent dosing or staggered dosing

MRTX849

David S. Hong, MD

To find the recommended dose of MRTX849 that can be given in combination with cetuximab and irinotecan to patients with colorectal cancer that have a mutation (genetic change) called KRAS G12C.

Primary objectives:

* To determine the optimal biological dose (OBD) of MRTX849 when used in combination with cetuximab and irinotecan.
* To evaluate the safety profile of this combination.
* To determine the antitumor activity of this combination in patients with metastatic KRASG12C colorectal cancer.

Exploratory objectives:

* To explore correlations between MRTX849 exposure and patient outcomes such as disease response, objective response rate (ORR), duration or response (DOR), progression-free survival (PFS), overall survival (OS), safety, and pharmacodynamic endpoints.
* To evaluate the utility of detecting KRASG12C mutation in plasma to identify suitable patients.
* To explore potential pharmacodynamic (PD) markers of KRASG12C and EGFR inhibition in tumor tissue and/or blood plasma.
* To explore correlations between baseline tumor biomarkers, gene alterations, and clinical activity/efficacy.
* To define mechanisms of acquired resistance to EGFR and KRASG12C inhibition and evaluate novel strategies to overcome such resistance.
* To assess pharmacokinetics of MRTX849 and irinotecan and key metabolites.

Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

Mirati Therapeutics

M.D. Anderson Cancer Center

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Pancreatic Neoplasms

Neoplastic Processes

Pancreatic Cancer

Herbal and Botanical

Amino Acids

Pembrolizumab

Afatinib

Immune Checkpoint Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Cola

Tyrosine

Dose escalation of MRTX849 to determine maximum tolerated dose

Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens

Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC

Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)

MRTX849 will be administered orally once or twice daily in a continuous regimen

Pembrolizumab is administered as an intravenous infusion once every 3 weeks

Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks

Afatinib will be administered orally once a day in a continuous regimen

Mirati Therapeutics Study Locator Services

Hirak Der-Torossian

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

Number of participants with treatment related adverse events

Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Number of participants with dose limiting toxicity

Mirati Therapeutics Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Colonic Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination

Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963

BI 1701963

This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.

Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Number of patients with dose limiting toxicity

Boehringer Ingelheim

Palbociclib

Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.

Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.

This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Number of participants with treatment emergent adverse events

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Dose Escalation/Evaluation and Food Effect Assessment

MRTX0902 and adagrasib combination RP2D administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12C mutation to include the following: NSCLC, CRC, Other Solid Tumors

MRTX0902

Curtis Chin, MD, PhD

This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX0902 in combination with adagrasib.

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

A Phase 1/2 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Helps to control pancreatic cancer that has a KRAS G12 mutation.

Dan Zhao, MD

To learn if the investigational study drug, adagrasib (also called MRTX849), can help to control pancreatic cancer that has a KRAS G12 mutation. The safety and possible effects of adagrasib will also be studied.

Primary Objectives:

To assess the preliminary antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRAS G12C mutation using Objective Response Rate (ORR) = Complete response (CR)+Partial response (PR) by RECIST 1.1 criteria1.

Secondary Objectives:

To evaluate the safety, tolerability and antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRASG12C mutation including median overall survival (OS), progression free survival (PFS), safety and adverse events (AEs).

Exploratory objectives:

Exploratory objectives include identiying the genomic and nongenomic mechanisms to responses and resistance and the specific immune cells involved with outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer	NCT05722327	Colon Cancer Colorectal Canc...	MRTX849 Irinotecan Cetuximab	18 Years -	M.D. Anderson Cancer Center
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1	NCT03785249	Advanced Cancer Metastatic Canc... Malignant Neopl...	MRTX849 Pembrolizumab Cetuximab Afatinib	18 Years -	Mirati Therapeutics Inc.
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)	NCT04975256	Advanced Cancer Metastatic Canc... Malignant Neopl... Malignant Neopl... Malignant Neopl...	MRTX849 BI 1701963	18 Years -	Mirati Therapeutics Inc.
Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)	NCT05178888	Advanced Solid ...	MRTX849 Palbociclib	18 Years -	Mirati Therapeutics Inc.
A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway	NCT05578092	Solid Tumor Advanced Solid ... Non Small Cell ... Colo-rectal Can...	MRTX0902 MRTX849	18 Years -	Mirati Therapeutics Inc.
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1	NCT03785249	Advanced Cancer Metastatic Canc... Malignant Neopl...	MRTX849 Pembrolizumab Cetuximab Afatinib	18 Years -	Mirati Therapeutics Inc.
Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients	NCT05634525	Metastatic Panc...	MRTX849	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for mrtx849

Every month we try and update this database with for mrtx849 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mrtx849

Every month we try and update this database with for mrtx849 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mrtx849 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.