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Advanced Solid TumorsPhase 1NCT04989387

Study of INCA 0186 in Subjects With Advanced Solid Tumors

A Phase 1 study testing INCA00186, Retifanlimab and INCB106385 in people with Advanced Solid Tumors and Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Incyte Corporation at 32 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
INCA00186, Retifanlimab and INCB106385
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
32 sitesin 6 countries
Study dates
4 Oct 2021to 19 Sep 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

32 sites in 6 countries.

32 sites in 6 countries

United States8 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Md Anderson Cancer Center

    Houston, Texas, 77030

  • Carolina Bio-Oncology Institute, Pllc

    Huntersville, North Carolina, 28078

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

Other trials in United States

Spain6 sites

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035

  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

    Barcelona, 199203

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

United Kingdom6 sites

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle upon Tyne, NE7 7DN

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Institut Jules Bordet

    Brussels, B-1070

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650

  • Ghent University Hospital

    Ghent, 09000

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000

Other trials in Belgium

Netherlands5 sites

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • University Medical Center Groningen

    Groningen, 9713GZ

  • Radboud University Nijmegen Medical Center

    Nijmegen, 6525 GA

  • Erasmus Mc Cancer Institute

    Rotterdam, 3015GD

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Austria2 sites

  • Innsbruck University Hospital

    Innsbruck, A-6020

  • Landeskrankenhaus Salzburg

    Salzburg, 05020

Other trials in Austria

About this study

Official title: A Phase 1, Open-Label, Multicenter Study of INCA00186 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

Being tested
INCA00186, Retifanlimab, INCB106385
Keywords
open label, advanced solid tumors, squamous cell carcinoma of the head and neck, gastrointestinal malignancies, gastric/gastroesophageal junction cancer, hepatocellular carcinoma, pancreatic ductal adenocarcinoma, squamous carcinoma of the anal canal, colorectal cancer
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCA00186Drug

    INCA00186 will be administered every 2 weeks or 4 weeks as per protocol

  • RetifanlimabDrug

    Retifanlimab will be administered every 4 weeks as per protocol

  • INCB106385Drug

    INCB106385 will be administered orally once or twice a day.

Study groups in NCT04989387
Study groupRoleWhat they receive
Treatment Group A Dose Escalation and ExpansionExperimentalINCA00186 will be administered as monotherapy every 2 or every 4 weeks.
Receives: Drug: INCA00186
Treatment Group B1 Dose Escalation and ExpansionExperimentalINCA00186 will be administered in combination with retifanlimab. INCA00186 will be administered every 2 or 4 weeks and retifanlimab will be administered every 4 weeks.
Receives: Drug: INCA00186; Drug: Retifanlimab
Treatment Group B2 Dose Escalation and ExpansionExperimentalINCA00186 will be administered in combination with INCB106385. INCA00186 will be administered every 2 or 4 weeks and INCB106385 will be administered once or twice daily.
Receives: Drug: INCA00186; Drug: INCB106385
Treatment Group C Dose Escalation and ExpansionExperimentalINCA00186 will be administered in combination with retifanlimab and INCB106385. INCA00186 will be administered every 2 to 4 weeks, retifanlimab every 4 weeks and INCB106385 once or twice daily.
Receives: Drug: INCA00186; Drug: Retifanlimab; Drug: INCB106385

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the safety and tolerability of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by the number of participants with adverse eventsductions and withdrawal of treatment due to AEs

    Measured: 90 days after study completion totaling up to 27 months

  2. Evaluation of Dose-Limiting Toxicity (DLTs) of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by safety events during treatment

    Measured: 90 days after study completion totaling up to 27 months

  3. Evaluation of Recommended Dose for Expansion (RDE) of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by safety, PK and PD data

    Measured: 90 days after study completion totaling up to 27 months

Secondary outcomes (11)

  1. Determination of PK parameter Maximum Observed Plasma Concentration (Cmax) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  2. Determination of PK parameter of Time to Maximum Plasma Concentration (tmax) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  3. Determination of PK parameter of concentration at the end of the dosing interval (Ctau) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  4. Determination of PK parameter of area under the plasma or serum concentration-time curve (AUC) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  5. Determination of PK parameter of total clearance (CL) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  6. Determination of PK parameter of volume of distribution (Vz) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  7. Determination of PK parameter half-life (t1/2) for INCA00186

    Measured: Cycle 1 days 1, 2, 8, 15, 22; Cycle 2 days 1, 8; Day 1 of every other cycle starting at Cycle 4 (ie, Cycle 4 day 1, Cycle 6 day 1, etc; each cycle is 28 days) + 30 day follow-up; approximately 24 months

  8. Intratumoral effect of INCA0186 on CD73 enzymatic activity

    Measured: 2 biopsy samples will be taken: pre-treatment and on-treatment on Cycle 1 Day 22 (for every 2 week INCA00186 dosing group) or Cycle 2 Day 8 (for every 4 week INCA00186 dosing group); each cycle is 28 days; sampling will be taken within 2 months.

  9. Objective Response Rate (ORR) by radiographic disease assessment

    Measured: Baseline through end of study up, to 24 months

  10. Disease Control Response (DCR) determined by radiographic disease assessment

    Measured: Baseline through end of study, up to 24 months

  11. Duration of Response (DOR) from earliest date of disease response until earliest date of disease progression as determined by radiographic disease assessment, or death if occurring sooner than progression

    Measured: Baseline through end of study, up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start4 Oct 2021
  3. Primary completion19 Sep 2024
  4. Study completion19 Sep 2024

Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989387
Sponsor's protocol ID
INCA 0186-101
Other IDs
2021-001263-24
Status last verified
Aug 2025
First submitted
22 Jul 2021
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qi C, McCammant MS, Li Y, Zhu W, Yu Z, Carlsen P, Han H, Zhao L, Zhang F, Huang T, Gan P, Qian D, Hoang G, He C, Mei S, Harris JJ, Gallion A, Hansbury M, Mason J, Stump K, Kurzeja-Lipinski K, DiRamio A, Covington M, Koblish H, Diamond S, Wang H, Scherle P, Yao W, Wang X. Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. J Med Chem. 2026 Jun 11;69(11):13899-13918. doi: 10.1021/acs.jmedchem.6c00964. Epub 2026 May 27.

    PubMed 42201333

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCA00186, Retifanlimab and INCB106385 in people with Advanced Solid Tumors and Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Incyte Corporation at 32 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, United Kingdom, Belgium, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the safety and tolerability of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by the number of participants with adverse eventsductions and withdrawal of treatment due to AEs (time frame: 90 days after study completion totaling up to 27 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04989387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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