INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
NCT ID: NCT04580485
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2021-02-03
2024-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group A (TGA) - INCB106385
In 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.
INCB106385
INCB106385 will be administered orally QD
Treatment Group B (TGB) - INCB106385+INCMGA00012
In 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.
INCB106385
INCB106385 will be administered orally QD
INCMGA00012
INCMGA0012 will be administered IV once every 4 weeks (Q4W)
Interventions
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INCB106385
INCB106385 will be administered orally QD
INCMGA00012
INCMGA0012 will be administered IV once every 4 weeks (Q4W)
Eligibility Criteria
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Inclusion Criteria
* 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.
* ECOG performance status 0 to 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy or fathering children based.
* Acceptable laboratory parameters
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ilona Rybicka, M.D
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cedars-Sinai Medical Center
West Hollywood, California, United States
University of Maryland-Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Cliniques Universitaires Ucl Saint-Luc
Brussels, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
Institut Bergonie
Bordeaux, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
A.O.U. Di Modena - Policlinico
Modena, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, , Italy
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Clinica Universidad de Navarra (Cun)
Pamplona, , Spain
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, , United Kingdom
University of Glasgow
Glasgow, , United Kingdom
Guys and St Thomas Nhs Foundation Trust
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester, , United Kingdom
Countries
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Other Identifiers
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2020-002921-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 106385-102
Identifier Type: -
Identifier Source: org_study_id
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