MedTrace Logo

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

NCT04580485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-07-11

No results posted yet for this study

Summary

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

Conditions

Interventions

DRUG

INCB106385

INCB106385 will be administered orally QD

DRUG

INCMGA00012

INCMGA0012 will be administered IV once every 4 weeks (Q4W)

Sponsors & Collaborators

Principal Investigators

  • Ilona Rybicka, M.D · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2024-01-22
Completion
2024-01-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT04580485 on ClinicalTrials.gov