INCB161734 for Solid Tumors

Recruiting at 37 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: KRAS G12D inhibitors

Disqualifiers: Invasive malignancy, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years and 90 days

466 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called INCB161734 to see if it is safe for cancer patients. Researchers are checking if it can be used alone or with other treatments without causing harmful side effects.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success, be intolerant to them, or have no other treatment options available to improve their condition.

Inclusion Criteria

I have been diagnosed with colorectal cancer.

My condition worsened after standard treatment, or I can't tolerate/have no standard treatment options.

My condition is an advanced solid tumor not classified in groups 1, 2, or 3.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB161734 as a single agent or in combination with other anticancer therapies

Up to 2 years and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• Cetuximab
• INCB161734
• Retifanlimab

Trial Overview The study tests the safety and effects of INCB161734 alone or combined with anticancer therapies like Cetuximab and Retifanlimab. It aims to find out how well these treatments work on various solid tumors with the KRAS G12D mutation.

Participant Groups

Group I: Part 2b: Dose Expansion combination Experimental Treatment 5 Interventions

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

Group II: Part 2a: Dose Escalation combination Experimental Treatment 5 Interventions

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

Group III: Part 1d: Food-Effect Experimental Treatment 1 Intervention

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

Group IV: Part 1c: Pharmacodynamic cohort Experimental Treatment 1 Intervention

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

Group V: Part 1b: Dose Expansion monotherapy Experimental Treatment 1 Intervention

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

Group VI: Part 1a: Dose Escalation monotherapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School