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INCA 0186 Combination Therapy for Cancer

Phase 1
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 or 1.
Participants with specified GI malignancies: Histologically or cytologically confirmed advanced or metastatic colorectal (CRC), gastric/gastroesophageal junction (GEJ) cancer, hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), or squamous carcinoma of the anal canal (SCAC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through end of study, up to 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and works well. They will test it on people with certain types of advanced cancer who have not responded to other treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immunotherapy such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is advanced and confirmed in the GI area, such as colorectal, stomach, liver, pancreas, or anal canal.
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I have squamous cell carcinoma in my mouth or throat that cannot be cured with surgery or radiation.
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My cancer is advanced and confirmed in the GI area, such as colorectal, stomach, liver, pancreas, or anal canal.
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I am fully active or can carry out light work.
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My tumor is CD8 T-cell positive.
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I am willing to have tumor biopsies before and during treatment.
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I have squamous cell carcinoma in my mouth or throat that cannot be cured with surgery or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through end of study up, to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end of study up, to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Dose-Limiting Toxicity (DLTs) of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by safety events during treatment
Evaluation of Recommended Dose for Expansion (RDE) of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by safety, PK and PD data
Evaluation of the safety and tolerability of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by the number of participants with adverse eventsductions and withdrawal of treatment due to AEs
Secondary outcome measures
Determination of PK parameter Maximum Observed Plasma Concentration (Cmax) for INCA00186
Determination of PK parameter half-life (t1/2) for INCA00186
Determination of PK parameter of Time to Maximum Plasma Concentration (tmax) for INCA00186
+8 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~320
INCB106385
2021
Completed Phase 1
~60

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gastrointestinal cancers, particularly those involving immunotherapy, include immune checkpoint inhibitors and chimeric antigen receptor (CAR) T-cell therapies. Immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 antibodies, work by blocking proteins that prevent T-cells from attacking cancer cells, thereby enhancing the immune response against tumors. CAR T-cell therapies involve modifying a patient's T-cells to express receptors that specifically target cancer cells. These treatments are significant for gastrointestinal cancer patients as they offer a targeted approach to boost the body's immune system to fight cancer, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
368 Previous Clinical Trials
55,404 Total Patients Enrolled
Ilona Rybicka, MDStudy DirectorIncyte Corporation

Media Library

Gastrointestinal Cancers Research Study Groups: Treatment Group C Dose Escalation and Expansion, Treatment Group A Dose Escalation and Expansion, Treatment Group B1 Dose Escalation and Expansion, Treatment Group B2 Dose Escalation and Expansion
Gastrointestinal Cancers Clinical Trial 2023: INCA00186 Highlights & Side Effects. Trial Name: NCT04989387 — Phase 1
~17 spots leftby Jun 2025
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