Overview

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

Status:
Active, not recruiting
Trial end date:
2021-09-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Biosciences International Sàrl
Incyte Corporation
Treatments:
Antibodies, Monoclonal
Ipilimumab
Nivolumab
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).