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

NCT03910530 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: INCMGA 0012-104
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Keywords

Advanced solid tumors; metastatic solid tumors; INCMGA00012; INCB001158; Japan; PD-1 Inhibitor; Arginase Inhibitor

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012

  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 approximately 2 years

• Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158

  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 approximately 2 years

• Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012

  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 approximately 2 years

Secondary Outcomes (24)

• Part 1: Cmax of single-agent INCMGA000012

  Up to 15 days

• Part 1: Cmax of single-agent INCB001158

  Up to 15 days

• Part 1: Tmax of single-agent INCMGA000012

  Up to 15 days

• Part 1: Tmax of single-agent INCB001158

  Up to 15 days

• Part 1: Cmin of single-agent INCMGA000012

  Up to 15 days

Study Arms (4)

INCMGA00012

EXPERIMENTAL

Single-agent INCMGA00012.

Drug: Retifanlimab

INCB001158 75 mg

EXPERIMENTAL

Single-agent INCB001158.

Drug: INCB001158

INCB001158 100 mg

EXPERIMENTAL

Single-agent INCB001158.

Drug: INCB001158

INCMGA00012 + INCB001158

EXPERIMENTAL

Combination of INCMGA00012 and INCB001158.

Drug: Retifanlimab + INCB001158

Interventions

Retifanlimab DRUG

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

Also known as: INCMGA00012

INCMGA00012

INCB001158 DRUG

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

INCB001158 100 mg; INCB001158 75 mg

Retifanlimab + INCB001158 DRUG

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

Also known as: INCMGA00012

INCMGA00012 + INCB001158

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Biosciences Japan GK: lead

Study Sites (2)

National Cancer Center Hospital

Chūōku, 1040045, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

Study Officials

• Eiji Ueda, MD, PhD, MBA

  Incyte Biosciences Japan GK

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: July 22, 2019
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)