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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975256
• Other study ID #: 849-014
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: December 2022
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 15, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)

• Unresectable or metastatic disease

• No available treatment with curative intent

• Adequate organ function

Exclusion Criteria:

• History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow

• Other active cancer

• Cardiac abnormalities

Related Conditions & MeSH terms

• Advanced Cancer
• Colonic Neoplasms
• Lung Neoplasms
• Malignant Neoplasm of Colon
• Malignant Neoplasm of Lung
• Malignant Neoplastic Disease
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• MRTX849
KRAS G12C inhibitor
• BI 1701963
SOS1 Inhibitor

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Next Oncology	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation	Number of participants with treatment related adverse events	20 months
Primary	Evaluate Pharmacokinetics of the combination regimen	Blood plasma concentration	20 months
Primary	Establish Maximum Tolerated Dose	Number of patients with dose limiting toxicity	12 months
Secondary	Evaluate preliminary clinical activity of the combination regimen	Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)	20 months