INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

July 9, 2025 updated by: Incyte Corporation

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 01200
        • Cliniques Universitaires Ucl Saint-Luc
      • Leuven, Belgium, 03000
        • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • France
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Toulouse, France, 31059
        • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
      • Villejuif, France, 94800
        • Institut Gustave Roussy
  • Italy
      • Modena, Italy, 41124
        • A.O.U. Di Modena - Policlinico
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitario Vall D Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra (CUN)
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Glasgow, United Kingdom, G12 0YN
        • University of Glasgow
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare Nhs Trust - Hammersmith Hospital
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Manchester, United Kingdom, M20 4BV
        • The Christie Nhs Foundation Trust Uk
  • United States
    • California
      • West Hollywood, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland-Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to comprehend and willingness to sign an ICF.
  • Willing and able to conform to and comply with all Protocol requirements.
  • Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).
  • Willingness to undergo pre- and on-treatment tumor biopsy.
  • Have CD8 T-cell-positive tumors.
  • Presence of measurable disease according to RECIST v1.1.
  • ECOG performance status 0 to 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children based.
  • Acceptable laboratory parameters

Exclusion Criteria:

  • Clinically significant cardiac disease.
  • Known or active CNS metastases and/or carcinomatous meningitis.
  • Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
  • Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment.
  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
  • Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
  • Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage.
  • Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Any prior radiation therapy within 28 days before the first dose of study treatment.
  • Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Concomitant treatment with strong CYP3A4 inhibitors or inducers.
  • Receipt of a live vaccine within 30 days of the first dose of study treatment.
  • Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment.
  • Evidence of HBV or HCV infection or risk of reactivation.
  • Known history of HIV (HIV 1/2 antibodies).
  • History of organ transplant, including allogeneic stem-cell transplantation.
  • Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components.
  • Presence of a gastrointestinal condition that may affect drug absorption.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group A (TGA) - INCB106385

In part 1 dose escalation, the dose levels will be escalated following a BOIN design.

In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.
Drug: INCB106385
INCB106385 will be administered orally QD
Experimental: Treatment Group B (TGB) - INCB106385+INCMGA00012

In part 1 dose escalation, the dose levels will be escalated following a BOIN design.

In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.
Drug: INCB106385
INCB106385 will be administered orally QD
Drug: INCMGA00012
INCMGA0012 will be administered IV once every 4 weeks (Q4W)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent adverse events (TEAE)
Time Frame: Up to Approximately 28 months
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
Up to Approximately 28 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of INCB106385 as a single agent or in combination with INCMGA00012
Time Frame: Up to 6 months
Maximum observed plasma concentration.
Up to 6 months
Tmax of INCB106385 as a single agent or in combination with INCMGA00012
Time Frame: Up to 6 months
Time to maximum plasma concentration
Up to 6 months
Cmin of INCB106385 as a single agent or in combination with INCMGA00012
Time Frame: Up to 6 months
Minimum observed plasma concentration over the dose interval
Up to 6 months
AUC of INCB106385 as a single agent or in combination with INCMGA00012
Time Frame: Up to 6 months
Area under the plasma concentration-time curve
Up to 6 months
CL/F of INCB106385 as a single agent or in combination with INCMGA00012
Time Frame: Up to 6 months
Apparent oral dose clearance
Up to 6 months
Objective Response Rate (ORR)
Time Frame: Up to approximately 24 months
Defined as the percentage of participants with a best overall response of CR or PR, as determined by investigator radiographic disease assessment according to RECIST v1.1.
Up to approximately 24 months
Disease Control Rate
Time Frame: Up to approximately 24 months
Defined as the percentage of participants with a best overall response of CR, PR, or SD, as determined by investigator radiographic disease assessment according to RECIST v1.1.
Up to approximately 24 months
Duration Of Response (DOR)
Time Frame: Up to approximately 24 months
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.
Up to approximately 24 months
Change in tumoral gene expression
Time Frame: Predose and Week 5-6
Defined as the percent of patients with change in tumoral targeted gene expression compared to baseline
Predose and Week 5-6
Change in immune cell activation in tumors
Time Frame: Predose and Week 5-6
Defined as the percent of patients demonstrating change in immune cell activation in tumors compared to baseline
Predose and Week 5-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ilona Rybicka, M.D, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB 106385-102
  • 2020-002921-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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