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Ovarian CancerPhase 1NCT04580485

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

A Phase 1 study testing INCB106385 and INCMGA00012 in people with Ovarian Cancer and Bladder Cancer, run by Incyte Corporation at 27 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCB106385 and INCMGA00012
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
27 sitesin 6 countries
Study dates
3 Feb 2021to 22 Jan 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • ECOG performance status 0 to 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children based.
  • Acceptable laboratory parameters

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

27 sites in 6 countries.

27 sites in 6 countries

United States8 sites

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Md Anderson Cancer Center

    Houston, Texas, 77030

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Cedars-Sinai Medical Center

    West Hollywood, California, 90048

Other trials in United States

Spain5 sites

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008

Other trials in Spain

United Kingdom5 sites

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ

  • University of Glasgow

    Glasgow, G12 0YN

  • 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

Other trials in United Kingdom

Italy4 sites

  • A.O.U. Di Modena - Policlinico

    Modena, 41124

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134

Other trials in Italy

France3 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Belgium2 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

Other trials in Belgium

About this study

Official title: 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)

Being tested
INCB106385, INCMGA00012
Keywords
INCB106385, Advanced Solid Tumors, PD-1
Medical subject headings
Ovarian Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

  • INCB106385Drug

    INCB106385 will be administered orally QD

  • INCMGA00012Drug

    INCMGA0012 will be administered IV once every 4 weeks (Q4W)

Study groups in NCT04580485
Study groupRoleWhat they receive
Treatment Group A (TGA) - INCB106385ExperimentalIn 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.
Receives: Drug: INCB106385
Treatment Group B (TGB) - INCB106385+INCMGA00012ExperimentalIn 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.
Receives: Drug: INCB106385; Drug: INCMGA00012

What is being measured

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

  1. Number of treatment-emergent adverse events (TEAE)

    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.

    Measured: Up to Approximately 28 months

Secondary outcomes (10)

  1. Cmax of INCB106385 as a single agent or in combination with INCMGA00012

    Maximum observed plasma concentration.

    Measured: Up to 6 months

  2. Tmax of INCB106385 as a single agent or in combination with INCMGA00012

    Time to maximum plasma concentration

    Measured: Up to 6 months

  3. Cmin of INCB106385 as a single agent or in combination with INCMGA00012

    Minimum observed plasma concentration over the dose interval

    Measured: Up to 6 months

  4. AUC of INCB106385 as a single agent or in combination with INCMGA00012

    Area under the plasma concentration-time curve

    Measured: Up to 6 months

  5. CL/F of INCB106385 as a single agent or in combination with INCMGA00012

    Apparent oral dose clearance

    Measured: Up to 6 months

  6. Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 24 months

  7. Disease Control Rate

    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.

    Measured: Up to approximately 24 months

  8. Duration Of Response (DOR)

    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.

    Measured: Up to approximately 24 months

  9. Change in tumoral gene expression

    Defined as the percent of patients with change in tumoral targeted gene expression compared to baseline

    Measured: Predose and Week 5-6

  10. Change in immune cell activation in tumors

    Defined as the percent of patients demonstrating change in immune cell activation in tumors compared to baseline

    Measured: Predose and Week 5-6

Timeline

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

  1. First posted8 Oct 2020
  2. Study start3 Feb 2021
  3. Primary completion22 Jan 2024
  4. Study completion22 Jan 2024

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
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580485
Sponsor's protocol ID
INCB 106385-102
Other IDs
2020-002921-27
Status last verified
Jul 2025
First submitted
22 Sep 2020
Last updated
11 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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 INCB106385 and INCMGA00012 in people with Ovarian Cancer and Bladder Cancer, run by Incyte Corporation at 27 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Spain, United Kingdom, Italy, France 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of treatment-emergent adverse events (TEAE) (time frame: Up to Approximately 28 months). 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 NCT04580485, 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 11 Jul 2025.

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