Brief Title: Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Advanced Malignancies
• Metastatic Cancer

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 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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: John E. Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION