INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

  • End date
    Apr 10, 2024
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 11 July 2022
measurable disease
bladder tumor
cancer of the ovary


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)

Condition Ovarian Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer, Castration Resistant Prostate Cancer, Colorectal Cancer, Gastric/ Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Squamous Carcinoma of the Anal Canal
Treatment INCMGA00012, INCB106385
Clinical Study IdentifierNCT04580485
SponsorIncyte Corporation
Last Modified on11 July 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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