A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB1305 inParticipants with Advanced/Metastatic Solid Tumors
Contact:
NCT Number:
Protocol:
AAAV8261
Study Status:
Active/Enrolling
Population:
Adult
Phase:
I
The purpose of this study is to test whether combining two investigational study drugs, DB-1311 with BNT327 or DB-1311 with DB-1305, is safe and can be tolerated by participants with advanced or metastatic solid tumors. The study will also test how much of the study drugs are in the blood at different times, if the body makes antibodies against the study drugs, and how the study drugs affect the disease. Additionally, the study may also explore how certain molecules in the blood or tissue (biomarkers) relate to the drug's effects. DB-1311, BNT327, and DB-1305 are investigational drugs, meaning they haven't been approved by the Food and Drug Administration. This is the first time these drug combinations will be tested together in humans.
Are you Eligible? (Inclusion Criteria)
- You are an adult aged 18 years or older 2. You are capable of comprehending trial procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the trial and the schedule of assessments. 3. You have least one measurable lesion as assessed by the Investigator
Specialty Area(s)
Gynecologic Cancers, Cervical Cancer, Head and Neck/Oral Cancers, Lung cancer, Skin cancers, Melanoma, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
