Trial NCT06589596
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
- Phase
- Phase 1
- Sponsor
- BeOne Medicines
- Conditions
- Advanced Solid Tumor
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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) ≥ 70Performance status
* Life expectancy ≥ 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 compressionBrain metastases
* 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 curativelyPrior malignancy
* Significantly impaired pulmonary function
* Clinically significant infections
* Serologically active hepatitis B or C infection
* Known human immunodeficiency virus (HIV) infection.HIV 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)Cardiac
* 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 breastfeedingPregnancy
* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (6)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
QTcF > 470 ms
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1 or KPS ≥ 70
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
within 2 years
Show in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County