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New drug combo tested for tough cancers, but study halted early

NCT ID NCT03522142

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental drug called INCB081776, alone or with an immunotherapy (retifanlimab), in 83 adults with advanced solid tumors like lung, kidney, or melanoma cancer. The goal was to check safety and find the right dose. However, the study was terminated early, so the full picture is unclear.

What this could mean

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

Active substance
INCB081776 (an experimental drug) and retifanlimab (an immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This was an early Phase 1 trial, so safety and dosing were still being figured out. The study was terminated early, so results are limited and may not lead to a usable treatment.

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

83 people

The number who actually took part.

Started

Aug 2018

Finished

Sep 2025

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 years and older

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: • Male and female participants at least 18 years of age with advanced malignancies who have received or been intolerant to standard therapy: Parts 1A and 2A: * Histologically confirmed advanced or metastatic gastric or GEJ adenocarcinoma, HCC, melanoma, NSCLC, RCC, soft-tissue sarcoma, SCCHN (recurrent or metastatic), TNBC, or urothelial carcinoma. Additional tumor histologies, including MSI-H tumors, may be allowed with approval from the medical monitor. * Measurable disease per RECIST v1.1. Parts 1B and 2B: • Histologic confirmation of the cohort-specific tumor types specified below: Cohort 1 - Advanced or metastatic melanoma Cohort 2 - Advanced or metastatic NSCLC Cohort 3 - Recurrent or metastatic SCCHN Cohort 4 - Advanced or metastatic soft-tissue sarcoma * Cohorts 1-3 must have received 1 prior PD-1/L1 treatment and have experienced PD during or after that treatment and have progressed on other SOC therapy(ies); Cohort 4 must be PD-1/L1 treatment naïve but have progressed on SOC therapy(ies). * Measurable disease per RECIST v1.1. * Must be willing to submit to a fresh baseline tumor biopsy and an on-treatment biopsy between Cycle 2 Day 1 and Cycle 3 Day 1. * Care should be taken to biopsy the same lesion for the baseline and on-treatment samples. If a participant has a solitary target lesion, this should not be biopsied. Part 1C: * Participants with relapsed/refractory AML following standard therapy; acute promyelocytic leukemia (M3) and therapy-related AML are excluded. * FLT3-ITD and IDH1/2 wild-type or mutated are eligible; appropriate targeted therapy for participants with actionable mutations must have been received. Exclusion Criteria: * Laboratory values not within the protocol-defined range. * History of retinal disease as defined in the protocol. * Clinically significant cardiac disease as per protocol-defined criteria. * History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria. * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed as per protocol-defined criteria. * Active or inactive autoimmune disease or syndrome that has required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease. * Prior Grade 3 or higher immune-related AEs or any ocular toxicity on prior immunotherapy as per protocol-defined criteria. * Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or treatment with any anticancer medications or investigational drugs within the protocol-defined intervals. * Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment. * Active infection requiring systemic therapy. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of HIV (HIV 1/2 antibodies).

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As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Haukeland University Hospital

    Bergen, 05021, Norway

  • Karolinska University Hospital Solna

    Stockholm, 171 76, Sweden

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Odense University Hospital

    Odense C, 05000, Denmark

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen, 02100, Denmark

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Skane University Hospital Lund

    Lund, 22185, Sweden

  • University Medical Center Groningen

    Groningen, 9713GZ, Netherlands

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Utprøvingsenheten, Oslo University Hospital Radiumhospitalet

    Oslo, 00379, Norway

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

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