Clinical trial NCT05329298: A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
Official title: A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Phase I: The adverse events (AEs)
timeFrame: Through the Phase I, approximately 24 months
measure: Phase I: Determine the recommended Phase II dose (RP2D)
timeFrame: Through the Phase I, approximately 24 months
measure: Phase II: the objective response rate (ORR)
timeFrame: Through the Phase II, approximately 24 months
Secondary outcomes:
measure: Phase I: Evaluate the pharmacokinetics of BPI-361175
timeFrame: Through the Phase I, approximately 24 months
measure: Phase I: the objective response rate (ORR)
timeFrame: Through the Phase I, approximately 24 months
measure: Phase II: Disease control rate (DCR)
timeFrame: Through the Phase II, approximately 24 months
measure: Phase II: Progression free survival (PFS)
timeFrame: Through the Phase II, approximately 24 months
measure: Phase II: Overall survival (OS)
timeFrame: Through the Phase II, approximately 24 months
measure: Phase II: Duration of response (DOR)
timeFrame: Through the Phase II, approximately 24 months
measure: Phase II: The adverse events (AEs)
timeFrame: Through the Phase II, approximately 24 months
measure: Phase I: Disease control rate (DCR)
timeFrame: Through the Phase I, approximately 24 months
measure: Phase I: Progression free survival (PFS)
timeFrame: Through the Phase I, approximately 24 months
measure: Phase I: Overall survival (OS)
timeFrame: Through the Phase I, approximately 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Hangzhou
country: China
facility: the First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: Jianying Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: