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RecruitingPhase 1

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

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BG-75202 alone and with other treatments in adults with advanced breast cancer or other solid tumors. It looks at safety, side effects, how the drug moves through and acts in the body, and whether it may help fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Part 1A: Tests must confirm advanced breast cancer or another solid tumor that has spread. Standard treatments must have been used up, caused side effects you could not tolerate, or not be available.
  • Parts 1B and 2A: You must have advanced breast cancer and have had 1 to 3 rounds of treatment plans that work throughout the body for cancer that has spread. No more than 2 may be chemotherapy, including antibody drugs that carry chemotherapy.
  • Parts 2B and 2C: You must have advanced breast cancer and live where CDK4/6 inhibitors, a type of cancer drug, are not approved or available as the first treatment. You must not have used these drugs or had treatment that works throughout the body for advanced cancer.
  • For breast cancer, your latest tissue or cell test must confirm advanced breast cancer using the required guidelines.
  • Women with breast cancer that has spread must have gone through menopause or be getting treatment to stop the ovaries from working.
  • Your tumors must be measurable using the study's rules.
  • Your ability to do daily activities must be stable: you must be fully active or able to do light work despite limits on hard physical activity.
  • Your organs must work well enough for the study.

Who can't join

  • You have used drugs that block or break down proteins called KAT6A/B or KAT7.
  • You have active cancer in the lining around the brain or spinal cord, or cancer that has spread to the brain and is untreated or not controlled.
  • You have had another cancer within 3 years before screening. Exceptions include the cancer being studied and cancer that returned in the same area, was treated to cure it, and is unlikely to need treatment during the study, in the study doctor's view.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment. * Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function. Exclusion Criteria: * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study sites (6)

AL

CT

MO

TX

WA