NCT03910530CompletedPhase 1
A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
Incyte Biosciences Japan GK2 sites in 1 country18 target enrollmentStarted: July 22, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Incyte Biosciences Japan GK
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
INCMGA00012
Experimental
Single-agent INCMGA00012.
Intervention: Retifanlimab (Drug)
INCB001158 75 mg
Experimental
Single-agent INCB001158.
Intervention: INCB001158 (Drug)
INCB001158 100 mg
Experimental
Single-agent INCB001158.
Intervention: INCB001158 (Drug)
INCMGA00012 + INCB001158
Experimental
Combination of INCMGA00012 and INCB001158.
Intervention: Retifanlimab + INCB001158 (Drug)
Outcomes
Primary Outcomes
Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
Time Frame: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012
Time Frame: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158
Time Frame: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Secondary Outcomes
- Part 1: Cmin of single-agent INCB001158(Up to 15 days)
- Part 1: t½ of single-agent INCMGA000012(Up to 15 days)
- Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with single-agent INCB001158(Up to 2 years)
- 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 INCB001158(Up to 15 days)
- Part 1: Cmin of single-agent INCMGA000012(Up to 15 days)
- Part 1: AUCt of single-agent INCB001158(Up to 15 days)
- Part 1: Tmax of single-agent INCMGA000012(Up to 15 days)
- Part 1: AUCt of single-agent INCMGA000012(Up to 15 days)
- Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Disease control rate with single-agent INCMGA00012(Up to 2 years)
- Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with single-agent INCMGA00012(Up to 2 years)
- Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Duration of response with single-agent INCMGA00012(Up to 2 years)
- Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Duration of response with single-agent INCB001158(Up to 2 years)
- Part 1: t½ of single-agent INCB001158(Up to 15 days)
- Part 1 and Part 2: Disease control rate with single-agent INCB001158(Up to 2 years)
Investigators
Study Sites (2)
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