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 Advanced Solid Tumors
BeOne Medicines
Summary
This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
Description
BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer. This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested alone, in combination with BG-89894, and in combination with standard of care therapy in participants with advanced solid tumors and with MTAP deficiency. Note: Our company, previousl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must sign the ICF and be capable of giving written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70 * Life expectancy ≥ 3 months * Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue * Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after r…
Interventions
- DrugBGB-58067
Planned doses administered on specified days per protocol.
- DrugBG-89894
Planned doses administered on specified days per protocol.
- DrugStandard of Care Therapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Locations (62)
- Usc Norris Comprehensive Cancer Center (Nccc)Los Angeles, California
- AdventhealthCelebration, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Washington University School of MedicineSt Louis, Missouri
- Nyu Langone HealthNew York, New York
- Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania