RecruitingPhase 1Phase 2NCT04282031

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer

A Phase 1/2a Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of BPI-1178 Alone in Advanced Solid Tumor and of BPI-1178 in Combination With Endocrine Therapy in Advanced HR+/HER2- Breast Cancer


Sponsor

Beta Pharma (Suzhou) Co., Ltd.

Enrollment

224 participants

Start Date

Jun 15, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called BPI-1178 in people with advanced solid tumors, with a focus on hormone receptor-positive, HER2-negative breast cancer that has come back or spread. The early phase tests safety in many cancer types; the later phase focuses specifically on breast cancer. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor that has stopped responding to standard treatment (Phase 1), OR - You have hormone receptor-positive, HER2-negative breast cancer that is locally advanced or metastatic (Phase 2) - You have not responded to previous therapies or have no good standard options left **You may NOT be eligible if...** - You have had too many prior chemotherapy treatments - You have serious medical conditions affecting organ function - Your cancer does not meet the specific type and stage criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBPI-1178

BPI-1178 once daily on Days 1 to 21 of a 28-day cycle

DRUGFulvestrant

Fulvestrant 500mg intramuscularly on Days 1 and 15 of Cycle 1, and on Day 1 of Cycle 2 and beyond

DRUGLetrozole

Letrozole 2.5 mg once daily of a 28-day cycle

DRUGBPI-1178

BPI-1178 once daily of a 28-day cycle


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04282031


Related Trials