RECRUITING

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

Talk to us

Conditions

Advanced Solid TumorBGB-58067MTAP deficiencyBG-89894

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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

Quick Facts

Study Start:2024-10-11
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06589596

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must sign the ICF and be capable of giving written informed consent
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70
  3. * Life expectancy ≥ 3 months
  4. * Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue
  5. * Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing
  6. * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator
  7. * Adequate organ function
  1. * Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
  2. * Active leptomeningeal disease or symptomatic spinal cord compression
  3. * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  4. * 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
  5. * Significantly impaired pulmonary function
  6. * Clinically significant infections
  7. * Serologically active hepatitis B or C infection
  8. * Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria
  9. * High cardiovascular risk factors
  10. * QTcF \> 470 ms based on the screening triplicate 12-lead ECG records and/or a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)
  11. * Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized
  12. * Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function
  13. * Female participants who are pregnant or are breastfeeding
  14. * Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019
United States
Adventhealth
Celebration, Florida, 34747-4606
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010
United States
Nyu Langone Health
New York, New York, 10016-2708
United States
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107-4307
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Next Dallas
Irving, Texas, 75039-2743
United States
Next Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11
Study Completion Date2027-06

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • advanced solid tumor
  • BGB-58067
  • MTAP deficiency
  • BG-89894

Additional Relevant MeSH Terms

  • Advanced Solid Tumor