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Study of INCA 0186 in Subjects With Advanced Solid Tumors

NCT04989387 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-09-02

No results posted yet for this study

Summary

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

Conditions

  • Advanced Solid Tumors
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Gastrointestinal (GI) Malignancies

Interventions

DRUG

INCA00186

INCA00186 will be administered every 2 weeks or 4 weeks as per protocol

DRUG

Retifanlimab

Retifanlimab will be administered every 4 weeks as per protocol

DRUG

INCB106385

INCB106385 will be administered orally once or twice a day.

Sponsors & Collaborators

Principal Investigators

  • Ilona Rybicka, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2024-09-19
Completion
2024-09-19
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04989387 on ClinicalTrials.gov