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

NCT04282031 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-08-07

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor
  • HR+/HER2- Breast Cancer

Interventions

DRUG

BPI-1178

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

DRUG

Fulvestrant

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

DRUG

Letrozole

Letrozole 2.5 mg once daily of a 28-day cycle

DRUG

BPI-1178

BPI-1178 once daily of a 28-day cycle

Sponsors & Collaborators

  • Beta Pharma (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282031 on ClinicalTrials.gov