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A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

NCT03059823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2025-08-03

No results posted yet for this study

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors

Interventions

DRUG

retifanlimab

Anti-PD-1 monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • Incyte Medical Monitor · 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
2016-11-15
Primary Completion
2024-05-22
Completion
2024-05-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • China
  • Finland
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • New Zealand
  • Poland
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03059823 on ClinicalTrials.gov