Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-75202 · 2 trials · 3 indications
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not. An SAE is any untoward medical occurrence that, at any dose, * Results in death * Is life-threatening * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement
The potential RDFE(s) of BG-75202 as monotherapy or in combination with HMA are based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD), with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.
CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.
CR + CRh rate is defined as the percentage of participants who achieved the best response of CR or CRh as assessed by investigator's review.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.
The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A: Dose escalation, BG-75202 monotherapy | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
| Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated. |
| Phase 1b: Dose optimization, BG-75202 monotherapy | EXPERIMENTAL | Participants will receive BG-75202 monotherapy |
| Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
| Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. |
| Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist | EXPERIMENTAL | Participants will receive BG-75202 in combination with an estrogen receptor antagonist. |
| Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | EXPERIMENTAL | Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. |
| Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | EXPERIMENTAL | Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. |
| Name | Type | Description |
|---|---|---|
| BG-75202 | DRUG | Administered orally |
| Hypomethylation Agent (HMA) | DRUG | Administered Intravenous (IV) or Subcutaneous (SC) |
| CDK4 Inhibitor | DRUG | Administered orally. |
| Estrogen Receptor Antagonist | DRUG | Administered by intramuscular injection. |
| Aromatase Inhibitor | DRUG | Administered orally. |
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 He...
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BG-75202 is an investigational small molecule being studied for the treatment of breast cancer, advanced solid tumors, and myeloid malignancies. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BG-75202 targets KAT6A, an enzyme involved in gene regulation, and acts as an inhibitor of this protein. By inhibiting KAT6A, the drug aims to interfere with cancer cell growth and survival in the studied tumor types.
BG-75202 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BG-75202 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being tested in clinical trials to assess its safety, tolerability, and potential efficacy.
BG-75202 is being studied in two Phase 1 trials. NCT07222267 evaluates the drug alone and in combination with other agents in adults with advanced solid tumors, including breast cancer, across the US, Australia, China, Italy, New Zealand, and Spain. NCT07619287 studies it in patients with myeloid malignancies in Australia, China, and New Zealand.
BG-75202 is the primary name used for this investigational drug in clinical trials and company communications. No alternative names have been reported for this compound in the available clinical trial information.