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
Summary
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.
Arms & interventions
- DrugBG-75202
Administered orally.
- DrugCDK4 Inhibitor
Administered orally.
- DrugEstrogen Receptor Antagonist
Administered by intramuscular injection.
- DrugAromatase Inhibitor
Administered orally.
Outcome measures
Primary
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
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
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
Part 1: ORR
Time frame: Up to approximately 1 year
Part 1: Duration of Response (DOR)
Time frame: Up to approximately 1 year
Part 1: Time to Response (TTR)
Time frame: Up to approximately 1 year
Part 2: DOR
Time frame: Up to approximately 2 years
Part 2: TTR
Time frame: Up to approximately 2 years
Part 2: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Part 2: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 2 years
Part 2: Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Part 2: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Part 2: Recommended Phase 2 Dose (RP2D)
Time frame: Up to approximately 2 years
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202
Time frame: Up to approximately 4 months
Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Time frame: Up to approximately 4 months
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Time frame: Up to approximately 4 months
Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202
Time frame: Up to approximately 4 months
Eligibility criteria
Study locations (6)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
Yale Cancer Center
New Haven, Connecticut, 06510
Washington University in St Louis
St Louis, Missouri, 63110-1010
Next Oncology Austin
Austin, Texas, 78758
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433