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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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,108 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity for this clinical experiment?

"In order to initiate the medical trial, Incyte Corporation needs 210 patients meeting certain inclusion criteria. The sponsor will be launching this experiment at several different hospitals including Emory University in Atlanta and Vanderbilt Medical Center in Nashville."

Answered by AI

How many hubs are being utilized to manage this clinical trial?

"Eight clinical trial sites are currently enrolling participants, such as Emory University in Atlanta, Vanderbilt Medical Center in Nashville and South Texas Accelerated Research Therapeutics in San Antonio. In addition, there are 5 other participating medical centres."

Answered by AI

Is this experimental research a pioneering endeavor?

"INCA00186 has been a subject of research since 2016, with Incyte Corporation as the original sponsor. After its initial trial involving 325 patients in 2016, INCA00186 achieved Phase 1 drug approval and is now available for 26 live studies spread across 117 cities and 43 countries worldwide."

Answered by AI

Is enrollment for this clinical trial available to participants at the present time?

"Affirmative, the details hosted by clinicaltrials.gov state that this research is actively recruiting patients. The trial was initially posted on October 4th 2021 and recently updated November 23rd 2022. 210 participants are needed to be enrolled across 8 medical sites."

Answered by AI

Are there any precedents for the application of INCA00186 in clinical studies?

"Currently, there are 26 medical trials actively examining the effects of INCA00186; 3 of these studies have entered Phase 3. In addition to A CORUÏ¿½A and Virginia, 810 other sites worldwide are conducting research on this drug."

Answered by AI

Is the age criterion for eligibility in this experiment above or below 70 years old?

"This clinical trial is accepting participants of legal age (18+) and no older than 90 years old."

Answered by AI

Is it possible for me to join the research being conducted?

"To qualify for this trial, applicants must have oral squamous cell carcinoma and be between 18-90 years of age. The desired participant count is 210 individuals in total."

Answered by AI

How effective is INCA00186 in ameliorating patient symptoms?

"With limited efficacy and safety data, INCA00186's risk profile earned it a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of INCA 0186 in Subjects With Advanced Solid Tumors
2021. "Study of INCA 0186 in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04989387.
All > Hcc > Hepatocellular Carcinoma
~18 spots leftby Jun 2025
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