CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
INCB106385 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04580485
NCT04580485Phase 1Completed
CompareCT.gov

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

Incyte Corporation·interventional·Posted Oct 8, 2020·Updated Jul 11, 2025

In Brief

A Phase 1 clinical trial evaluating INCB106385 and INCMGA00012 for Ovarian Cancer and 10 related conditions. Completed, enrolled 54 participants across 27 sites in 6 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian 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
CountriesBelgium, France, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 8, 2020
Enrollment StartFeb 3, 2021
Primary CompletionJan 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.7 years ago

Interventions

INCB106385drug

INCB106385 will be administered orally QD

INCMGA00012drug

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