A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

NCT ID: NCT03910530

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2021-12-14

Brief Summary

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

Conditions

Advanced Solid Tumors; Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCMGA00012

Single-agent INCMGA00012.

Group Type: EXPERIMENTAL

Retifanlimab

Intervention Type: DRUG

Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.

INCB001158 75 mg

Single-agent INCB001158.

Group Type: EXPERIMENTAL

INCB001158

Intervention Type: DRUG

Part 1: INCB001158 75 or 100 mg twice daily administered orally.

INCB001158 100 mg

Single-agent INCB001158.

Group Type: EXPERIMENTAL

INCB001158

Intervention Type: DRUG

Part 1: INCB001158 75 or 100 mg twice daily administered orally.

INCMGA00012 + INCB001158

Combination of INCMGA00012 and INCB001158.

Group Type: EXPERIMENTAL

Retifanlimab + INCB001158

Intervention Type: DRUG

Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .

Interventions

Retifanlimab

Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.

Intervention Type: DRUG

INCB001158

Part 1: INCB001158 75 or 100 mg twice daily administered orally.

Intervention Type: DRUG

Retifanlimab + INCB001158

Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .

Intervention Type: DRUG

Other Intervention Names

INCMGA00012; INCMGA00012

Eligibility Criteria

Inclusion Criteria

• Participant is Japanese
• Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy.
• Participants with nonevaluable lesions are allowed.
• Life expectancy > 3 months.
• Eastern Cooperative Oncology Group performance status 0 to 1.
• Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
• Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
• Male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study.

Exclusion Criteria

• Receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas; 7 days for tyrosine kinase inhibitors.
• Radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy.
• Toxicity of prior therapy and/or complications from surgical intervention that has not recovered to ≤ Grade 1 or baseline within 7 days before starting study drug treatment (with the exception of anemia not requiring transfusion support and any grade of alopecia). Note: Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
• Receipt of prior systemic treatment with an arginase inhibitor
• Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
• Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
• Known active central nervous system metastases and/or carcinomatous meningitis.
• Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection.
• Known HIV infection.
• Active infections requiring systemic therapy.
• Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity ≥ Grade 3, or severe reaction, to study treatments or any of their excipients or additives.
• Participants with impaired cardiac function or clinically significant cardiac disease.
• Evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease.
• Participant is pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Biosciences Japan GK

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eiji Ueda, MD, PhD, MBA

Role: STUDY_DIRECTOR

Incyte Biosciences Japan GK

Locations

National Cancer Center Hospital

Chūōku, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Countries

Japan

Other Identifiers

INCMGA 0012-104

Identifier Type: -

Identifier Source: org_study_id