A Study of BPI-460372 in Advanced Solid Tumor Patients

January 22, 2025 updated by: Betta Pharmaceuticals Co., Ltd.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients

This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Yutao Liu
    • Hebei
      • Baoding, Hebei, China, 050031
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Aimin Zang
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Yan Yu
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical College Of Hust
        • Contact:
          • Qian Chu
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Lin Wu
    • Jilin
      • Changchun, Jilin, China, 130033
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
          • Linlin Liu
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Ligang Xing
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Central Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Meili Sun
        • Contact:
          • Qing Wen
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Dongqing Lv
    • Zhengzhou
      • Zhengzhou, Zhengzhou, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Xingya Li

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent;
  • Age ≥18, male and female patients；
  • Expected survival ≥ 3 months；
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  • Dose escalation phase: 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: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
  • Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;

Exclusion Criteria:

  • Patients who have previously received a TEAD inhibitor;
  • Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；
  • Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
  • Pregnancy or lactation;
  • Other conditions considered not appropriate to participate in this trial by the investigators.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD).
Drug: BPI-460372
Subjects will receive BPI-460372 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-460372 administered, once daily (QD)
Drug: BPI-460372
Subjects will receive BPI-460372 until disease progression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The 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 (AEs).
Through the Phase I, approximately 24 months
Determine the Maximum Tolerated Dose (MTD)
Time Frame: Through the Phase I, approximately 24 months
The MTD will be based on DLT.
Through the Phase I, approximately 24 months
The dose-limiting toxicity（DLT）
Time Frame: Through the Phase I, approximately 24 months
The dose-limiting toxicity
Through the Phase I, approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the pharmacokinetics of BPI-460372
Time Frame: Time Frame: Through the Phase I, approximately 24 months
Based on blood plasma concentration
Time Frame: Through the Phase I, approximately 24 months
Evaluate the effectiveness of BPI-460372
Time Frame: Time Frame: Through the Phase I, approximately 24 months
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1
Time Frame: Through the Phase I, approximately 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Betta Pharmaceuticals Co., Ltd.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTP-661911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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