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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04975256

Enrollment

Registered

2021-07-23

Start date

2021-07-28

Completion date

2022-11-15

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGMRTX849

KRAS G12C inhibitor

DRUGBI 1701963

SOS1 Inhibitor

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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	20 months	Number of participants with treatment related adverse events
Evaluate Pharmacokinetics of the combination regimen	20 months	Blood plasma concentration
Establish Maximum Tolerated Dose	12 months	Number of patients with dose limiting toxicity

Secondary

Measure	Time frame	Description
Evaluate preliminary clinical activity of the combination regimen	20 months	Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026