Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BPI-572270.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
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).
Interventions
- Drug BPI-572270
Oral Tablets
Primary outcome measures
- DLT [Time frame: up to 2 tears]
- RP2D [Time frame: up to 2 tears]
- ORR [Time frame: up to 3 tears]
Secondary outcome measures (3)
- Cmax [Time frame: up to 15 weeks]
- AUC [Time frame: up to 15 weeks]
- Disease Control Rate (DCR) [Time frame: up to 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07435038 · BTP-662011