A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination with Anticancer Agents in Patients With Advance Solid Tumors

Contact:

NCT Number:

Protocol:

ACYY1223

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to test if the study drug (BGB-58067) alone and the study drug combinations including tislelizumab and chemotherapy (carboplatin, cisplatin, pemetrexed, paclitaxel, nab-paclitaxel, gemcitabine, fluorouracil, leucovorin, irinotecan, and oxaliplatin) are safe and tolerable, test how your body processes the study drug/the study drug combinations, find the safest and most appropriate dose(s) and test if it/they work in patients with advanced solid tumor who have methylthioadenosine phosphorylase (MTAP) deficiency, including those with a loss of MTAP or no MTAP expression. MTAP is is a gene that produces an enzyme necessary for normal cell health.BGB-58067 has not been approved by the Food and Drug Administration (FDA). Tislelizumab and chemotherapy is FDA approved but not in combination with BGB-58067.

Are you Eligible? (Inclusion Criteria)

  • Patients must sign the ICF and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 2. Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the informed consent. 3. Patients must be able to provide an archived tumor tissue sample (FFPE block or approximately 17-21 freshly cut unstained slides) or unstained fresh biopsy if there is no archival tissue at baseline. a. Tissue sample obtained after the most recent line of therapy is preferred.

Specialty Area(s)

Colon and Rectal Cancer, Esophageal Cancer, Liver Cancer, Lung cancer, Pancreatic Cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
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