INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

NCT04580485 | Completed Phase 1 FDA Drug

• 2 other identifiers: INCB 106385-1022020-002921-27
• Study Type: interventional
• Target: 54
• Locations: 6 countries
• Sites: 27

Brief 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 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)

Conditions

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

Keywords

INCB106385; Advanced Solid Tumors; PD-1

Outcome Measures

Primary Outcomes (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.

  Up to Approximately 28 months

Secondary Outcomes (10)

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

  Up to 6 months

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

  Up to 6 months

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

  Up to 6 months

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

  Up to 6 months

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

  Up to 6 months

Study Arms (2)

Treatment Group A (TGA) - INCB106385

EXPERIMENTAL

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.

Drug: INCB106385

Treatment Group B (TGB) - INCB106385+INCMGA00012

EXPERIMENTAL

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.

Drug: INCB106385; Drug: INCMGA00012

Interventions

INCB106385 DRUG

INCB106385 will be administered orally QD

Treatment Group A (TGA) - INCB106385; Treatment Group B (TGB) - INCB106385+INCMGA00012

INCMGA00012 DRUG

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

Treatment Group B (TGB) - INCB106385+INCMGA00012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (27)

Cedars-Sinai Medical Center

West Hollywood, California, 90048, United States

Location

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

A.O.U. Di Modena - Policlinico

Modena, 41124, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

Verona, 37134, Italy

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

Location

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra (Cun)

Pamplona, 31008, Spain

Location

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

University of Glasgow

Glasgow, G12 0YN, United Kingdom

Location

Guys and St Thomas Nhs Foundation Trust

London, SE1 9RT, United Kingdom

Location

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BV, United Kingdom

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Liver Neoplasms; Liver Diseases

Study Officials

• Ilona Rybicka, M.D

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: February 3, 2021
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

BE (2); FR (3); US (8); IT (4); ES (5); GB (5)