Clinical trial NCT03910530: A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors
Official title: A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Metastatic Solid Tumors
Keywords: Advanced solid tumors
metastatic solid tumors
INCMGA00012
INCB001158
Japan
PD-1 Inhibitor
Arginase Inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
timeFrame: Up to approximately 2 years
measure: Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158
timeFrame: Up to approximately 2 years
measure: Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Part 1: Cmax of single-agent INCMGA000012
timeFrame: Up to 15 days
measure: Part 1: Cmax of single-agent INCB001158
timeFrame: Up to 15 days
measure: Part 1: Tmax of single-agent INCMGA000012
timeFrame: Up to 15 days
measure: Part 1: Tmax of single-agent INCB001158
timeFrame: Up to 15 days
measure: Part 1: Cmin of single-agent INCMGA000012
timeFrame: Up to 15 days
measure: Part 1: Cmin of single-agent INCB001158
timeFrame: Up to 15 days
measure: Part 1: AUCt of single-agent INCMGA000012
timeFrame: Up to 15 days
measure: Part 1: AUCt of single-agent INCB001158
timeFrame: Up to 15 days
measure: Part 1: t½ of single-agent INCMGA000012
timeFrame: Up to 15 days
measure: Part 1: t½ of single-agent INCB001158
timeFrame: Up to 15 days
measure: Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment
timeFrame: Up to 15 days
measure: Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment
timeFrame: Up to 15 days
measure: Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment
timeFrame: Up to 15 days
measure: Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment
timeFrame: Up to 15 days
measure: Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment
timeFrame: Up to 15 days
measure: Part 1 and Part 2: Overall response rate with single-agent INCMGA00012
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Overall response rate with single-agent INCB001158
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Disease control rate with single-agent INCMGA00012
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Disease control rate with single-agent INCB001158
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Duration of response with single-agent INCMGA00012
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Duration of response with single-agent INCB001158
timeFrame: Up to 2 years
measure: Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
Study officials:
affiliation: Incyte Biosciences Japan GK
name: Eiji Ueda, MD, PhD, MBA
role: STUDY_DIRECTOR
References: