Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

Mirati Therapeutics

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: MRTX849; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05178888

CA239-0018

849-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.

Treatment:

Drug: Palbociclib

Drug: MRTX849

Dose Expansion

Experimental group

Description:

Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.

Treatment:

Drug: Palbociclib

Drug: MRTX849