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Experimental cancer drug trial ends early

NCT ID NCT04272034

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage study tested an experimental drug called INCB099318 in people with advanced solid tumors that had stopped responding to standard treatments. The main goal was to check the drug's safety and how the body processes it. The study was terminated early, so results are limited.

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

105 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 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 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: * Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment. * Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures. * ECOG performance status score of 0 or 1. * Life expectancy \> 12 weeks. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Exclusion Criteria: * Laboratory values outside the Protocol-defined ranges. * Clinically significant cardiac disease. * History or presence of an ECG that, in the investigator's opinion, is clinically meaningful. * Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). * Known additional malignancy that is progressing or requires active treatment. * Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment. * Prior receipt of an anti-PD-L1 therapy. * Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * A 28-day washout for systemic antibiotics is required. * Probiotic usage while on study and during screening is prohibited. * Active infection requiring systemic therapy. * Known history of HIV * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

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Conditions

The condition(s) this trial relates to.

anal carcinoma anus neoplasm basal cell carcinoma cervical cancer cutaneous neuroendocrine carcinoma endometrium neoplasm esophageal squamous cell carcinoma mesothelioma nasopharyngeal carcinoma Neoplasm Metastasis renal cell carcinoma sarcomatoid renal cell carcinoma skin squamous cell carcinoma small cell lung carcinoma squamous cell carcinoma of penis transitional cell carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Advanced solid tumors Anal carcinoma Basal cell carcinoma (unresectable or metastatic) Cervical cancer Clear cell ovarian or endometrial carcinoma Cutaneous squamous cell carcinoma Cyclin-dependent kinase 12 mutated tumors DNA polymerase epsilon mutated tumors (P286R and V411L) Esophageal squamous cell carcinoma Merkel cell carcinoma Mesothelioma Msi-H/DMMR tumors Nasopharyngeal carcinoma PD-L1 amplified tumor (9p24.1) Sarcomatoid renal cell carcinoma Small cell lung cancer Squamous cell penile carcinoma Urothelial carcinoma, HCC

Contacts and locations

Locations

  • Docrates Cancer Center

    Helsinki, 00180, Finland

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • 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

  • Haukeland University Hospital

    Bergen, 05051, Norway

  • Helsinki University Central Hospital

    Helsinki, 00029, Finland

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Institut Jules Bordet

    Brussels, B-1070, Belgium

  • Karolinska University Hospital Solna

    Solna, 17164, Sweden

  • Oslo University Hospital

    Oslo, 00450, Norway

  • Prisma Health Cancer Institute Faris

    Greenville, South Carolina, 29605, United States

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen, 02100, Denmark

  • Sahlgrenska University Hospital

    Gothenburg, 41345, Sweden

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Tampere University Hospital

    Tampere, 33520, Finland

  • The Royal Marsden Hospital Nhs Trust London

    London, SM2 5PT, United Kingdom

  • Turku University Hospital

    Turku, 20520, Finland

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • Universitair Ziekenhuis Brussel

    Brussels, 01090, Belgium

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Uppsala Universitet - Akademiska Sjukhuset

    Uppsala, 75185, Sweden

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

More trials for these conditions

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