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COMPLETED Phase 1

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

NCT04580485 · View on ClinicalTrials.gov ↗

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)

Interventions

  • DRUG INCMGA00012
  • DRUG INCB106385

Study Locations (20)

Other

  • Cliniques Universitaires Ucl Saint-Luc — Brussels
  • Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven
  • Institut Bergonie — Bordeaux
  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole — Toulouse
  • Institut Gustave Roussy — Villejuif
  • A.O.U. Di Modena - Policlinico — Modena
  • Istituto Nazionale Tumori Irccs Fondazione Pascale — Naples
  • Irccs Istituto Clinico Humanitas — Rozzano
  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) — Verona
  • Hospital General Universitario Vall D Hebron — Barcelona
  • Fundacion Jimenez Diaz University Hospital — Madrid
  • Hospital Universitario 12 de Octubre — Madrid

New York

  • Roswell Park Cancer Institute — Buffalo
  • Columbia University Medical Center — New York

Texas

  • Md Anderson Cancer Center — Houston
  • South Texas Accelerated Research Therapeutics — San Antonio

California

  • Cedars-Sinai Medical Center — West Hollywood

Maryland

  • University of Maryland-Greenebaum Cancer Center — Baltimore

Massachusetts

  • Dana Farber Cancer Institute — Boston

Pennsylvania

  • University of Pittsburgh — Pittsburgh

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2021-02-03
Est. Completion 2024-01-22
Phase Phase 1

Sponsor

Incyte Corporation

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04580485

The ClinicalTrials.gov registry entry for NCT04580485 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which INCMGA00012 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04580485 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04580485 about?

NCT04580485 is a clinical study titled "INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors". 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 C...

What is the current status of trial NCT04580485?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-02-03. Estimated completion is 2024-01-22.

What conditions does trial NCT04580485 study?

This clinical trial studies the following conditions: Colorectal Cancer, Ovarian Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Hepatocellular Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04580485?

The interventions under investigation include: INCMGA00012 (DRUG), INCB106385 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04580485?

This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04580485 being conducted?

This trial has 20 study locations across California, Maryland, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial