A Study of BPI-460372 in Advanced Solid Tumor Patients

NCT05789602 | Recruiting Phase 1

• 1 other identifier: BTP-661911
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• The adverse events (AEs)

  Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).

  Through the Phase I, approximately 24 months

• The dose-limiting toxicity（DLT）

  The dose-limiting toxicity

  Through the Phase I, approximately 24 months

• Determine the Maximum Tolerated Dose (MTD)

  The MTD will be based on DLT.

  Through the Phase I, approximately 24 months

Secondary Outcomes (2)

• Evaluate the pharmacokinetics of BPI-460372

  Time Frame: Through the Phase I, approximately 24 months

• Evaluate the effectiveness of BPI-460372

  Time Frame: Through the Phase I, approximately 24 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Dose Expansion

EXPERIMENTAL

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

Interventions

BPI-460372 DRUG

Subjects will receive BPI-460372 until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (11)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 050031, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

RECRUITING

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

NOT YET RECRUITING

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Zhengzhou, 450052, China

NOT YET RECRUITING

Central Study Contacts

Mengzhao Wang, Ph.D

CONTACT

010-69155039; mengzhaowang@sina.com

Xiaohong Han, Ph.D

CONTACT

010-69156114; hanxiaohong@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: April 24, 2023
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)