BG-75202 alone or with other drugs in myeloid malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1 interventional trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BG-75202, both as a single agent and in combination with other therapies for adults with myeloid malignancies. Patients must have relapsed or refractory disease after prior systemic therapy and an ECOG performance status of 0 to 2. The study excludes prior exposure to KAT6A/B inhibitors and certain leukemia subtypes, and requires a washout period from other antileukemic therapies. Locations include hospitals in Australia, with BeOne Medicines as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).
* Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:

  * Relapsed/refractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable/inaccessible, or declined by patient.
* Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

* Prior exposure to KAT6A/B inhibitors/degraders.
* A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.
* Known central nervous system involvement by leukemia
* Use of antileukemic therapies without sufficient washout period

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Concord Repatriation General Hospital
  Concord, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Icon Cancer Centre Kurralta Park
  Kurralta Park, South Australia, Australia Recruiting
• Barwon Health the Geelong Hospital
  Geelong, Victoria, Australia Recruiting
• Austin Health
  Heidelberg, Victoria, Australia Recruiting
• Linear Clinical Research
  Nedlands, Western Australia, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.