Health TrialsbyHealthPanel

An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors

ConditionsBreast CancerAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies.

Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).

Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.

Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.

Disqualifiers

Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.

Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BG-75202

    Drug

    Administered orally.

  • CDK4 Inhibitor

    Drug

    Administered orally.

  • Estrogen Receptor Antagonist

    Drug

    Administered by intramuscular injection.

  • Aromatase Inhibitor

    Drug

    Administered orally.

Treatment groups

86 Participants
are divided into 5 treatment groups
Group A: Part 1A: Dose Escalation and Safety Expansion, BG-75202 MonotherapyExperimental treatment 1 intervention
Group B: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor AntagonistExperimental treatment 2 interventions
Group C: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor AntagonistExperimental treatment 2 interventions
Group D: Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase InhibitorExperimental treatment 3 interventions
Group E: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase InhibitorExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with Adverse Events (AEs)

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.

Time frame
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
2

Part 1: Recommended Dose for Expansion (RDFE)

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.

Time frame
Estimated approximately 1 year
3

Part 2: Overall Response Rate (ORR)

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).

Time frame
Up to approximately 2 years

Secondary outcomes

1

Part 1: ORR

ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1.

Time frame
Up to approximately 1 year
2

Part 1: Duration of Response (DOR)

DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.

Time frame
Up to approximately 1 year
3

Part 1: Time to Response (TTR)

TTR is defined as the time from treatment initiation to the first determination of objective response.

Time frame
Up to approximately 1 year
4

Part 2: DOR

DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
Apply now