Primary Outcome Measures
- Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
- An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
- Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
Defined as the percentage of subjects having complete response (CR) or partial response (PR)
Secondary Outcome Measures
- Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1) [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
Defined as the percentage of subjects having CR or PR - Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause, if occurring sooner than progression. - Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
Defined as CR, PR, and stable disease (SD) as measured from first report of SD or better until disease progression or death from any cause, if occurring sooner than progression. - Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause, if occurring sooner than progression. - Phase 1 & Phase 2: Overall survival [ Time Frame: 1 year, 2 years, and end of study, up to 24 months ]
Determined from the start of combination therapy until death due to any cause. - Phase 1 & Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
Eligibility
- Inclusion Criteria
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic endometrial cancer, gastric cancer (including stomach, esophageal, and GEJ), and SCCHN.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Exclusion Criteria
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with an immune-therapy.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
- Prior treatment with an immune-therapy.
- Phase 1: Subjects with advanced or metastatic solid tumors.
