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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBetta Pharmaceuticals Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • BPI-572270

    Drug

    Oral Tablets

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Study BPI-572270 in adults with specific RAS mutant advanced solid tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

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

Time frame
up to 2 tears
2

RP2D

Determination of RP2D in the expansion phase

Time frame
up to 2 tears
3

ORR

Further expand the inclusion to clarify the efficacy endpoint ORR

Time frame
up to 3 tears

Secondary outcomes

1

Cmax

Maximum Observed Blood Concentration (Cmax) of BPI-572270

Time frame
up to 15 weeks
2

AUC

Area Under Blood Concentration Time Curve (AUC) of BPI-572270

Time frame
up to 15 weeks
3

Disease Control Rate (DCR)

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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