Phase
Condition
Advanced Malignancies
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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
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).
Study Design
Study Description
Connect with a study center
Institut Jules Bordet
Brussels, Belgium 1200
BelgiumActive - Recruiting
Hospital Clinic I Provincial
Barcelona, 08036
SpainActive - Recruiting
Clinica Universidad De Navarra (CUN)
Pamplona, 31008
SpainActive - Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, Madrid 28034
SpainActive - Recruiting
The Angeles Clinic and Research Institute
Los Angeles, California 90025
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesActive - Recruiting
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