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

RecruitingPhase 1Ages 18 Years - anyAllBeOne Medicines
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In plain words

What the trial is, and whether it could suit you

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 (discontinued), in combination with standard of care therapy, and in combination with novel anticancer therapies in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants must sign the Informed Consent Form and be capable of giving written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) โ‰ฅ 70 * Life expectancy โ‰ฅ 3 months * Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue; documented RAS mutation status or KRAS mutation is required for selected cohorts * 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 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; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts * Adequate organ function Exclusion Criteria: * 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 โ‰ค 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 human immunodeficiency virus (HIV) infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria * High cardiovascular risk factors * QT interval corrected by Fridericia's method (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) * 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) Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • BGB-58067
  • BG-89894
  • Standard of Care Therapy
  • RAS(ON) Inhibitors
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Where

101 sites
Cancer and Blood Specialty Clinic
Los Alamitos, United States
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, United States
Adventhealth
Celebration, United States
Dana Farber Cancer Institute
Boston, United States
Washington University School of Medicine
St Louis, United States
Nyu Langone Health
New York, United States
Columbia University Medical Center
New York, United States
Sidney Kimmel Cancer Center
Philadelphia, United States

โ€ฆand 93 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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