NCT05315180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2021

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

April 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

March 29, 2022

Last Update Submit

April 5, 2022

Conditions

Malignant NeoplasmsMetastatic Cancer

Keywords

Antineoplastic AgentsKRASNSCLCColorectal CancerPancreatic CancerKRAS G12C

Outcome Measures

Primary Outcomes (2)

  • Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies

    Number of subjects with treatment related adverse events

    20 months

  • determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen

    Number of subjects with dose limiting toxicity

    20 months

Secondary Outcomes (6)

  • Evaluate the pharmacokinetics of BPI-421286

    20 months

  • 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

  • To evaluate the duration of response (DOR) in subjects with CR or PR as best response

    20 months

  • to evaluate the disease control rate (DCR)

    20 months

  • To evaluate progression-free survival (PFS) following initiation of BPI-421286

    20 months

  • +1 more secondary outcomes

Study Arms (2)

dose exploration

EXPERIMENTAL

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

Drug: BPI-421286

dose expansion

EXPERIMENTAL

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

Drug: BPI-421286

Interventions

BPI-421286DRUG

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

dose expansiondose exploration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Shun Lu, Ph.D

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Dingzhi Huang, Ph.D

Tianjin, Tianjin Municipality, China

RECRUITING

Wen Li, Ph.D

Hangzhou, Zhejiang, 310009, China

RECRUITING

Yun Fan,Ph.D

Hangzhou, Zhejiang, 310022, China

RECRUITING

Shun Lu, Ph.D

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisColorectal NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Shun Lu, Ph.D

CONTACT

13601813062shun_lu@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 7, 2022

Study Start

August 24, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

April 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)