A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors

NCT05329298 | Unknown Phase 1

• 1 other identifier: BTP-661411
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Phase I: 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

• Phase I: Determine the recommended Phase II dose (RP2D)

  Number of subjects with dose limiting toxicity

  Through the Phase I, approximately 24 months

• Phase II: the objective response rate (ORR)

  The proportion of patients with complete response (CR) and partial response (PR) in all patients.

  Through the Phase II, approximately 24 months

Secondary Outcomes (10)

• Phase I: Evaluate the pharmacokinetics of BPI-361175

  Through the Phase I, approximately 24 months

• Phase I: the objective response rate (ORR)

  Through the Phase I, approximately 24 months

• Phase II: Disease control rate (DCR)

  Through the Phase II, approximately 24 months

• Phase II: Progression free survival (PFS)

  Through the Phase II, approximately 24 months

• Phase II: Overall survival (OS)

  Through the Phase II, approximately 24 months

Study Arms (2)

Phase I

EXPERIMENTAL

Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia). Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib).

Drug: BPI-361175

Phase II

EXPERIMENTAL

Patients receive BPI-361175 based on RP2D.

Drug: BPI-361175

Interventions

BPI-361175 DRUG

Subjects will receive BPI-361175 until disease progression

Phase I; Phase II

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years old;
• Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
• For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
• Measurable or evaluable disease;
• Adequate bone marrow, liver, and renal function.

You may not qualify if:

• Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
• Pregnancy or lactation;
• Other protocol specified criteria.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (8)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Hunan cancer hospital

Changsha, Hunan, 410013, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

the First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caicun Zhou, Ph.D

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Jianying Zhou, Ph.D

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou, Ph.D

CONTACT

021-65115006; fkzlkzhoudr@126.com

Jianying Zhou, Ph.D

CONTACT

0571-87236114; drzjy@163.com

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 31, 2022
• First Posted: April 15, 2022
• Study Start: July 21, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)