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

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: BPI-361175

Study type: Interventional

Funder types: Industry

Identifiers

NCT05329298

BTP-661411

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Phase I

Experimental group

Description:

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).

Treatment:

Drug: BPI-361175

Phase II

Experimental group

Description:

Patients receive BPI-361175 based on RP2D.

Treatment:

Drug: BPI-361175