A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors

Betta Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Metastatic Cancer; Malignant Neoplasms

Treatments: Drug: BPI-421286

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315180

BTP-661311

Details and patient eligibility

About

Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically documented, locally-advanced or metastatic malignancy
• Standard treatment is not available or patient declines
• Adequate organ function

Exclusion criteria

• Active brain metastases from non-brain tumors.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication.
• Other protocol specified criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

dose exploration

Experimental group

Description:

Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort

Treatment:

Drug: BPI-421286

dose expansion

Experimental group

Description:

dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently

Treatment:

Drug: BPI-421286