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CDK4/6 Inhibitor

phase 1 (dose escalation study, dose expansion study and PK trail) for Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Beta Pharma (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+/HER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.

Eligible Conditions
  • Solid Tumors
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Group I: phase 2a cohort BExperimental Treatment2 Interventions
Participants will receive BPI-1178 at dose levels of MTD, MTD-1 or MTD-2 in combination with letrozole for 3 consecutive weeks, followed by 1 week drug withdrawal or continuous dosing for 28 days, in each 28-day treatment cycle, until disease progression or unacceptable toxicity.
Group II: phase 2a cohort AExperimental Treatment2 Interventions
Participants will receive BPI-1178 at dose levels of MTD, MTD-1 or MTD-2 in combination with fulvestrant for 3 consecutive weeks, followed by 1 week drug withdrawal or continuous dosing for 28 days, in each 28-day treatment cycle, until disease progression or unacceptable toxicity.
Group III: phase 1 (dose escalation study, dose expansion study and PK trail)Experimental Treatment1 Intervention
Participants will first receive single dose BPI-1178 orally at dose levels of 25mg, 75mg, 150mg, 250mg, 400mg and 500mg followed by a 7-day washout period , and then start receiving the 28 days/cycle continuous treatment until disease progression or unacceptable toxicity. After the 500 mg dose escalation trial is completed, the PK study will be conducted for the 400 mg dose group, the 300 mg dose group and the 200 mg dose group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

Beta Pharma (Suzhou) Co., Ltd.Lead Sponsor
~12 spots leftby Dec 2024
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