search
Back to results

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

Primary Purpose

Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Colon

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRTX849
BI 1701963
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring KRAS G12C, SOS1 Inhibitor, NSCLC, CRC, Non Small Cell Lung Cancer, Colon Cancer, Advanced Solid Tumor, Metastatic Cancer, Pancreatic Cancer, adagrasib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine
  • The Cleveland Clinic Foundation
  • MD Anderson Cancer Center
  • Next Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose escalation

Dose expansion

Arm Description

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

Outcomes

Primary Outcome Measures

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
Evaluate Pharmacokinetics of the combination regimen
Blood plasma concentration
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity

Secondary Outcome Measures

Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Full Information

First Posted
July 6, 2021
Last Updated
December 6, 2022
Sponsor
Mirati Therapeutics Inc.
Collaborators
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT04975256
Brief Title
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Official Title
A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Colon, Malignant Neoplasm of Lung, Malignant Neoplastic Disease
Keywords
KRAS G12C, SOS1 Inhibitor, NSCLC, CRC, Non Small Cell Lung Cancer, Colon Cancer, Advanced Solid Tumor, Metastatic Cancer, Pancreatic Cancer, adagrasib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation
Arm Type
Experimental
Arm Description
Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
Arm Title
Dose expansion
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
MRTX849
Other Intervention Name(s)
KRAS G12C inhibitor, adagrasib
Intervention Description
KRAS G12C inhibitor
Intervention Type
Drug
Intervention Name(s)
BI 1701963
Other Intervention Name(s)
SOS1 Inhibitor
Intervention Description
SOS1 Inhibitor
Primary Outcome Measure Information:
Title
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
Description
Number of participants with treatment related adverse events
Time Frame
20 months
Title
Evaluate Pharmacokinetics of the combination regimen
Description
Blood plasma concentration
Time Frame
20 months
Title
Establish Maximum Tolerated Dose
Description
Number of patients with dose limiting toxicity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluate preliminary clinical activity of the combination regimen
Description
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Next Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs