NCT04975256

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

July 6, 2021

Last Update Submit

December 12, 2024

Conditions

Advanced CancerMetastatic CancerMalignant Neoplasm of ColonMalignant Neoplasm of LungMalignant Neoplastic Disease

Keywords

KRAS G12CSOS1 InhibitorNSCLCCRCNon Small Cell Lung CancerColon CancerAdvanced Solid TumorMetastatic CancerPancreatic Canceradagrasib

Outcome Measures

Primary Outcomes (3)

  • 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

  • Evaluate Pharmacokinetics of the combination regimen

    Blood plasma concentration

    20 months

  • Establish Maximum Tolerated Dose

    Number of patients with dose limiting toxicity

    12 months

Secondary Outcomes (1)

  • Evaluate preliminary clinical activity of the combination regimen

    20 months

Study Arms (2)

Dose escalation

EXPERIMENTAL

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

Drug: MRTX849Drug: BI 1701963

Dose expansion

EXPERIMENTAL

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

Drug: MRTX849Drug: BI 1701963

Interventions

MRTX849DRUG

KRAS G12C inhibitor

Also known as: KRAS G12C inhibitor, adagrasib
Dose escalationDose expansion
BI 1701963DRUG

SOS1 Inhibitor

Also known as: SOS1 Inhibitor
Dose escalationDose expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisColonic NeoplasmsLung NeoplasmsNeoplasmsCarcinoma, Non-Small-Cell LungPancreatic Neoplasms

Interventions

adagrasib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Richard Chao, MD

    Mirati Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 23, 2021

Study Start

July 28, 2021

Primary Completion

November 2, 2022

Study Completion

November 15, 2022

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)