Advanced Solid Tumors, Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Brief summary
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
DRUGBPI-572270
Oral Tablets
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | 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 |
| RP2D | up to 2 tears | Determination of RP2D in the expansion phase |
| ORR | up to 3 tears | Further expand the inclusion to clarify the efficacy endpoint ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 15 weeks | Maximum Observed Blood Concentration (Cmax) of BPI-572270 |
| AUC | up to 15 weeks | Area Under Blood Concentration Time Curve (AUC) of BPI-572270 |
| Disease Control Rate (DCR) | up to 3 years | — |
Outcome results
None listed