Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
BeOne Medicines (Voir sur ClinicalTrials)
janvier 2025
août 2028
21 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sophie POSTEL-VINAY | 05/10/2026 14:45:03 | Contacter | ||
Critères
Tous
- 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) ≥ 70
- 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 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 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.