A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Incyte

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Cetuximab; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: INCB161734; Drug: GEMNabP; Drug: FOLFIRI; Drug: Retifanlimab; Drug: INCA33890

Study type: Interventional

Funder types: Industry

Identifiers

NCT06179160

INCB161734-101

2023-507091-47-00 (Registry Identifier)

Details and patient eligibility

About

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Enrollment: 710 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old.
• Locally advanced or metastatic solid tumor with KRAS G12D mutation.
• For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.
• Cohort specific requirements aas defined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

• Prior treatment with any KRAS G12D inhibitor
• Known additional invasive malignancy within 1 year of the first dose of study drug
• History of organ transplant, including allogeneic stem cell transplantation
• Significant, uncontrolled medical condition
• History or presence of an ECG abnormality
• Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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710 participants in 6 patient groups

Part 1a: Dose Escalation monotherapy

Experimental group

Description:

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: INCB161734

Part 1b: Dose Expansion monotherapy

Experimental group

Description:

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: INCB161734

Part 1c: Pharmacodynamic cohort

Experimental group

Description:

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: INCB161734

Part 2a: Dose Escalation combination

Experimental group

Description:

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: INCA33890

Drug: Retifanlimab

Drug: FOLFIRI

Drug: GEMNabP

Drug: FOLFOX

Drug: INCB161734

Drug: mFOLFIRINOX

Drug: Cetuximab

Part 2b: Dose Expansion combination

Experimental group

Description:

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: INCA33890

Drug: Retifanlimab

Drug: FOLFIRI

Drug: GEMNabP

Drug: FOLFOX

Drug: INCB161734

Drug: mFOLFIRINOX

Drug: Cetuximab

Part 1d: Food-Effect

Experimental group

Description:

Evaluate food effect on drug exposure as defined in the protocol.

Treatment:

Drug: INCB161734