Clinical trial · Interventional
A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors
A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
NCT03910530CI-TRIAL-00056753completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB001158 | Drug | — | UNRESOLVED |
| Retifanlimab | Drug | Retifanlimab | ALIAS |
| Retifanlimab + INCB001158 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- INCMGA00012
- description
- Single-agent INCMGA00012.
- interventionNames
- Drug: Retifanlimab
- type
- EXPERIMENTAL
- label
- INCB001158 75 mg
- description
- Single-agent INCB001158.
- interventionNames
- Drug: INCB001158
- type
- EXPERIMENTAL
- label
- INCB001158 100 mg
- description
- Single-agent INCB001158.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.