NCT07435038

Brief Summary

Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
38mo left

Started Jan 2026

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
recruiting

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 Progress18%
Jan 2026Oct 2029

First Submitted

Initial submission to the registry

January 19, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2029

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

2.9 years

First QC Date

January 19, 2026

Last Update Submit

September 17, 2026

Conditions

Advanced Solid TumorsPancreatic Ductal Adenocarcinoma (PDAC)Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (3)

  • DLT

    Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs

    up to 2 tears

  • RP2D

    Determination of RP2D in the expansion phase

    up to 2 tears

  • ORR

    Further expand the inclusion to clarify the efficacy endpoint ORR

    up to 3 tears

Secondary Outcomes (3)

  • Cmax

    up to 15 weeks

  • AUC

    up to 15 weeks

  • Disease Control Rate (DCR)

    up to 3 years

Study Arms (1)

Study BPI-572270 in adults with specific RAS mutant advanced solid tumors

EXPERIMENTAL

Capsules; Administer once a day on an empty stomach.

Drug: BPI-572270

Interventions

BPI-572270DRUG

Oral Tablets

Also known as: BPI-572270 Capsule
Study BPI-572270 in adults with specific RAS mutant advanced solid tumors

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.
  • Have received prior standard therapy appropriate for tumor type and stage.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.

You may not qualify if:

  • Primary central nervous system (CNS) tumors active and untreated brain metastases.
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.
  • History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

NOT YET RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

GenesisCare St Leonards, 7 Westbourne St, St Leonards

Sydney, New South Wales, 2065, Australia

NOT YET RECRUITING

Southern Oncology Clinical Research Unit (SOCRU)

Bedford Park, South Australia, 5042, Australia

NOT YET RECRUITING

Warringal Private Hospital

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungColorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

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

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 27, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

December 28, 2028

Study Completion (Estimated)

October 28, 2029

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations

CN(1)AU(6)