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New drug combo tested for Hard-to-Treat cancers

NCT ID NCT04989387

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This early-phase trial tested an experimental drug called INCA00186, alone or with other immunotherapy drugs, in people with advanced solid tumors such as head and neck or gastrointestinal cancers. The study aimed to find safe doses and check for early signs of effectiveness. It was terminated early, so full results may not be available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INCA00186 (an experimental drug) given alone or with retifanlimab and/or INCB106385
What this could lead to
If it works, this could point toward a new treatment option for certain advanced solid tumors like head and neck or gastrointestinal cancers.
What could go wrong
This is a very early Phase 1 trial, so safety and effectiveness are not yet known. The study was terminated early, meaning results may be limited or inconclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

57 people

The number who actually took part.

Started

Oct 2021

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Male or female participant aged 18 years or older inclusive at the time of signing the ICF. * Must be willing and able to conform to and comply with all Protocol requirements * Willingness to undergo pre- and on-treatment tumor biopsy. * Have CD8 T-cell-positive tumors * ECOG performance status 0 or 1. * Measurable disease according to RECIST v1.1. * Participants with SCCHN: Participants with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). * Participants with specified GI malignancies: Histologically or cytologically confirmed advanced or metastatic colorectal (CRC), gastric/gastroesophageal junction (GEJ) cancer, hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), or squamous carcinoma of the anal canal (SCAC). * Participants should have disease progression after treatment with available therapies, including anti-PD-(L)1 therapy (if applicable), that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance. * For participants to be enrolled in cohorts including INCB106385: The ability to swallow oral medication. * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Clinically significant cardiac disease, unstable angina, acute myocardial infarction within 6 months of Cycle 1 Day 1, and New York Heart Association Class III or IV congestive heart failure. * History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful. * Known active CNS metastases and/or carcinomatous meningitis. * Participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * 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 with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease free \> 1 year after treatment with curative intent. * Participants with protocol specified exclusionary hematology, hepatic, renal and coagulation laboratory values at screening. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) 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. * Prior treatment with any adenosine pathway targeting drugs. * 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. * For participants to be enrolled in cohorts including INCB106385: concomitant treatment with strong CYP3A4 inhibitors or inducers. * Receipt of a live virus 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. * Known or suspected SARS-CoV-2 infection at the time of enrollment. * Active HBV or HCV infection that requires treatment. HBV-DNA and HCV-RNA must be undetectable. Participants who have cleared a prior HBV infection (defined as HBsAg negative, HBsAg antibody positive, and anti-HBc antibody positive) are eligible for the study. * Known history of HIV (HIV 1/2 antibodies). * History of organ transplant, including allogeneic stem-cell transplantation or CAR-T cell therapy. * Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components. * For participants to be enrolled in cohorts including INCB106385: Inability to swallow food or any concomitant condition of the upper GI tract that precludes administration of oral medications. * Is pregnant or breastfeeding. * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.

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Conditions

The condition(s) this trial relates to.

anal canal squamous cell carcinoma colorectal cancer colorectal neoplasm digestive system cancer gastric cancer gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma hepatocellular carcinoma neoplasm pancreatic ductal adenocarcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Gastrointestinal (GI) malignancies Squamous cell carcinoma of the head and neck (SCCHN)

Contacts and locations

Locations

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Carolina Bio-Oncology Institute, Pllc

    Huntersville, North Carolina, 28078, United States

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200, Belgium

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus Mc Cancer Institute

    Rotterdam, 3015GD, Netherlands

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040, Spain

  • Ghent University Hospital

    Ghent, 09000, Belgium

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital Clinico Universitario Virgen de La Victoria

    Málaga, 29010, Spain

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Innsbruck University Hospital

    Innsbruck, A-6020, Austria

  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

    Barcelona, 199203, Spain

  • Institut Jules Bordet

    Brussels, B-1070, Belgium

  • Landeskrankenhaus Salzburg

    Salzburg, 05020, Austria

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Radboud University Nijmegen Medical Center

    Nijmegen, 6525 GA, Netherlands

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229, United States

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV, United Kingdom

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    Sutton, SM2 5PT, United Kingdom

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000, Belgium

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • University Medical Center Groningen

    Groningen, 9713GZ, Netherlands

  • University Medical Center Utrecht

    Utrecht, 3584 CX, Netherlands

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.