The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | April 13, 2017 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: 1. Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
Primary Outcome 1 - Time Frame: Screening through 60 days after end of treatment, up to 18 months
Primary Outcome 2 - Measure: Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Primary Outcome 2 - Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months
Criteria:
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 cervical cancer, gastric cancer
(including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1
relapsed melanoma.
- 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 any tumor necrosis factor super family agonist.
- 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).
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: John E. Janik, MD
Role: Study Director
Affiliation: Incyte Corporation
Name: Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Email: medinfo@incyte.com