INCA 0186 Combination Therapy for Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called INCA00186, alone or with other drugs, in patients with advanced head and neck or gastrointestinal cancers that have CD8 T-cells. The treatment uses immunotherapy to help the immune system attack cancer cells.

Research Team

Ilona Rybicka, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

Adults over 18 with advanced solid tumors, specifically squamous cell carcinoma of the head and neck or certain gastrointestinal cancers. Participants must have CD8 T-cell-positive tumors, an ECOG performance status of 0 or 1, measurable disease, and be willing to undergo biopsies. They should have progressed after standard treatments including anti-PD-(L)1 therapy unless intolerant.

Inclusion Criteria

Measurable disease according to RECIST v1.1.

Measurable disease according to RECIST v1.1

I am willing to have tumor biopsies before and during treatment.

See 18 more

Exclusion Criteria

I have or had lung scarring or inflammation not caused by an infection.

History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful

I haven't had radiation therapy in the last 28 days.

See 23 more

Treatment Details

Interventions

INCA00186 (Other)
INCB106385 (Other)
Retifanlimab (Monoclonal Antibodies)

Trial OverviewThe trial is testing INCA00186 alone or combined with INCB106385 and/or retifanlimab in patients with specific advanced solid tumors. It's a Phase 1 study focusing on safety, tolerability, how the body processes the drugs (pharmacokinetics), their effects on the body (pharmacodynamics), and initial effectiveness.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Treatment Group C Dose Escalation and ExpansionExperimental Treatment3 Interventions

INCA00186 will be administered in combination with retifanlimab and INCB106385. INCA00186 will be administered every 2 to 4 weeks, retifanlimab every 4 weeks and INCB106385 once or twice daily.

Group II: Treatment Group B2 Dose Escalation and ExpansionExperimental Treatment2 Interventions

INCA00186 will be administered in combination with INCB106385. INCA00186 will be administered every 2 or 4 weeks and INCB106385 will be administered once or twice daily.

Group III: Treatment Group B1 Dose Escalation and ExpansionExperimental Treatment2 Interventions

INCA00186 will be administered in combination with retifanlimab. INCA00186 will be administered every 2 or 4 weeks and retifanlimab will be administered every 4 weeks.

Group IV: Treatment Group A Dose Escalation and ExpansionExperimental Treatment1 Intervention

INCA00186 will be administered as monotherapy every 2 or every 4 weeks.