Phase 1 Study of BPI-460372 in Advanced Solid Tumor Patients

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789602

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

20.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: BPI-460372	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 18, 2023

Anticipated Primary Completion Date :

Apr 17, 2025

Anticipated Study Completion Date :

Apr 17, 2026

Arms and Interventions

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-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

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-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

Outcome Measures

Primary Outcome Measures

The adverse events (AEs) [Through the Phase I, approximately 24 months]
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
The dose-limiting toxicity [Through the Phase I, approximately 24 months]
The dose-limiting toxicity
Determine the Maximum Tolerated Dose (MTD) [Through the Phase I, approximately 24 months]
The MTD will be based on DLT.

Secondary Outcome Measures

Evaluate the pharmacokinetics of BPI-460372 [Time Frame: Through the Phase I, approximately 24 months]
Based on blood plasma concentration
Evaluate the effectiveness of BPI-460372 [Time Frame: Through the Phase I, approximately 24 months]
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 compressionother， 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
2	Affiliated hospital of Hebei university	Baoding	Hebei	China	050031
3	Hunan cancer hospital	Changsha	Hunan	China	410031
4	Central hospital affiliated to shandong first medical university	Jinan	Shandong	China	250013

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05789602

Other Study ID Numbers:

BTP-661911

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Mar 29, 2023