A Study of BPI-452080 in Subjects With Solid Tumors

April 24, 2023 updated by: Betta Pharmaceuticals Co., Ltd.

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors

This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chengdu, China, 610041
        • West China Hospital of Sichuan University
        • Contact:
          • Zhenhua Liu
      • Hangzhou, China, 310000
        • Zhejiang Cancer Hospital
        • Contact:
          • Meiyu Fang
      • Hunan, China, 410031
        • Hunan Cancer Hospital
        • Contact:
          • Shusuan Jiang
      • Wuhan, China, 430000
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
          • Xiaoping Zhang
    • Shanghai
      • Shanghai, Shanghai, China, 201321
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists
  • Dose expansion phase:

Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors

  • Adequate organ function
  • Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase

Exclusion Criteria:

  • Has received prior treatment with another HIF-2α inhibitor
  • Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc
  • Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
Drug: BPI-452080
Subjects will receive BPI-452080 until disease progression
Experimental: Dose Expansion

Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.

Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors
Drug: BPI-452080
Subjects will receive BPI-452080 until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events (AEs)
Time Frame: Through the Phase I, approximately 24 months
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
Through the Phase I, approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Through the Phase I, approximately 24 months
Maximum observed concentration
Through the Phase I, approximately 24 months
Tmax
Time Frame: Through the Phase I, approximately 24 months
Time to reach maximum observed plasma concentration
Through the Phase I, approximately 24 months
t1/2
Time Frame: Through the Phase I, approximately 24 months
Half-life time
Through the Phase I, approximately 24 months
Progression free survival (PFS)
Time Frame: Through the Phase I, approximately 24 months
The time from the date of randomization to disease progression (PD) or death, whichever occurs first
Through the Phase I, approximately 24 months
the objective response rate（ORR）
Time Frame: Through the Phase I, approximately 24 months
The proportion of patients with complete response (CR) and partial response (PR) in all patients
Through the Phase I, approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Dingwei Ye, Ph.D, Fudan University
  • Principal Investigator: Jian Zhang, Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 28, 2023

Primary Completion (Anticipated)

March 25, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTP-661811

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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