OncRef

Clinical Trial: NCT04580485

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Incyte Corporation
Information Provided By:Incyte Corporation
Last Update Posted:2025-07-11

Study Overview

Brief 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)

Official Title

A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

Conditions

Ovarian Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer, Castration Resistant Prostate Cancer, Colorectal Cancer, Gastric/ Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Squamous Carcinoma of the Anal Canal

Intervention / Treatment

  • Drug: INCB106385
  • Drug: INCMGA00012

Other Study ID Numbers

  • INCB 106385-102
  • 2020-002921-27

Start Date (Actual)

2021-02-03

Primary Completion Date (Actual)

2024-01-22

Study Completion Date (Actual)

2024-01-22

Enrollment (Actual)

54

Study Type

Interventional

Phase

Phase 1