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

A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05315180

Enrollment

Registered

2022-04-07

Start date

2021-08-24

Completion date

2023-07-31

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasms, Metastatic Cancer

Keywords

Antineoplastic Agents, KRAS, NSCLC, Colorectal Cancer, Pancreatic Cancer, KRAS G12C

Brief summary

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.

Interventions

DRUGBPI-421286

Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies	20 months	Number of subjects with treatment related adverse events
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen	20 months	Number of subjects with dose limiting toxicity

Secondary

Measure	Time frame	Description
To evaluate the duration of response (DOR) in subjects with CR or PR as best response	20 months	Evaluate clinical activity/efficacy of BPI-421286
to evaluate the disease control rate (DCR)	20 months	Evaluate clinical activity/efficacy of BPI-421286
Evaluate the pharmacokinetics of BPI-421286	20 months	Blood plasma concentration
To evaluate overall (OS) following initiation of BPI-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286
To evaluate progression-free survival (PFS) following initiation of BPI-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286

Countries

China

Contacts

Primary ContactShun Lu, Ph.D

shun_lu@hotmail.com13601813062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026