About this trial
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
BPI-572270
DrugOral Tablets
Treatment groups
Trial outcomes
Primary outcomes
DLT
Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs
RP2D
Determination of RP2D in the expansion phase
ORR
Further expand the inclusion to clarify the efficacy endpoint ORR
Secondary outcomes
Cmax
Maximum Observed Blood Concentration (Cmax) of BPI-572270
AUC
Area Under Blood Concentration Time Curve (AUC) of BPI-572270
Disease Control Rate (DCR)
Sponsors and contacts
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