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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05178888

Enrollment

Registered

2022-01-05

Start date

2022-01-20

Completion date

2024-12-30

Last updated

2025-02-11

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

Conditions

Advanced Solid Tumor

Brief summary

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.

Detailed description

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.

Interventions

DRUGMRTX849

KRAS G12C inhibitor

DRUGPalbociclib

CDK 4 and 6 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 * Unresectable or metastatic disease. * No available treatment with curative intent * Adequate organ function

Exclusion criteria

* History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an 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.	24 months	Number of participants with treatment emergent adverse events
Evaluate Pharmacokinetics of the combination regimen	24 months	Plasma concentration
Establish Maximum Tolerated Dose	24 months	Number of patients with dose limiting toxicity
Evaluate preliminary clinical activity of the combination regimen	24 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 12, 2026