MedTrace Logo

A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

NCT03522142 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-10-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).

Conditions

Interventions

DRUG

INCB081776

INCB081776 administered once or twice daily orally with water after a fast of at least 2 hours before and at least 1 hour after the dose.

DRUG

INCMGA00012

INCMGA0012 administered intravenously according to the label as 500 mg every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Diane Hershock, MD · 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
2018-08-27
Primary Completion
2025-09-10
Completion
2025-09-10
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Netherlands
  • Norway
  • Sweden

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 NCT03522142 on ClinicalTrials.gov