INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
- Interventional
- Active
- NCT03589651
Contact Information
A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
- Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
- Willing to provide fresh or archival tumor tissue for correlative studies.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria:
- Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
- Laboratory values outside the protocol-defined range at screening.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
- Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
- Willing to provide fresh or archival tumor tissue for correlative studies.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria:
- Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
- Laboratory values outside the protocol-defined range at screening.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
- Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- Solid Tumors