INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Completed · Phase 1

Conditions studied: 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

In brief

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)

Key facts

Study ID

NCT04580485

Run by

Incyte Corporation

People needed

54

Starts

2021-02-03

Expected to finish

2024-01-22

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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