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

NCT07435038 | Not Yet Recruiting Phase 1

• 1 other identifier: BTP-662011
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

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-572270 DRUG

Oral Tablets

Also known as: BPI-572270 Capsule

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal 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: February 12, 2026
• Primary Completion (Estimated): December 28, 2028
• Study Completion (Estimated): October 28, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-01