Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

March 8, 2026 updated by: Betta Pharmaceuticals Co., Ltd.

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study BPI-572270 in adults with specific RAS mutant advanced solid tumors
Capsules; Administer once a day on an empty stomach.
Drug: BPI-572270
Oral Tablets
Other Names:
  • BPI-572270 Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: up to 2 tears
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
Time Frame: up to 2 tears
Determination of RP2D in the expansion phase
up to 2 tears
ORR
Time Frame: up to 3 tears
Further expand the inclusion to clarify the efficacy endpoint ORR
up to 3 tears

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 15 weeks
Maximum Observed Blood Concentration (Cmax) of BPI-572270
up to 15 weeks
AUC
Time Frame: up to 15 weeks
Area Under Blood Concentration Time Curve (AUC) of BPI-572270
up to 15 weeks
Disease Control Rate (DCR)
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2026

Primary Completion (Estimated)

December 28, 2028

Study Completion (Estimated)

October 28, 2029

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTP-662011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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