An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors

Description

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 as monotherapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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 as monotherapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-58067, an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumors

An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Usc Norris Comprehensive Cancer Center (Nccc), Los Angeles, California, United States, 90033

Celebration

Adventhealth, Celebration, Florida, United States, 34747

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Philadelphia

Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States, 19107

Houston

The University of Texas Md Anderson Cancer Center, Houston, Texas, United States, 77030-4009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 advanced, metastatic, or unresectable solid tumors, who have previously received standard systemic therapy or for whom treatment is not available or not tolerated
  • * Adequate organ function
  • * Prior treatment with any PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
  • * Active leptomeningeal disease or symptomatic spinal cord compression
  • * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  • * Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
  • * Significantly impaired pulmonary function
  • * Clinically significant infections
  • * Serologically active hepatitis B or C infection
  • * Known HIV infection
  • * High cardiovascular risk factors
  • * QTcF \> 470 ms based on the screening triplicate 12-lead ECG records
  • * Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized
  • * Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function
  • * Female participants who are pregnant or are breastfeeding
  • * Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2026-11