Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Oral Tablets
Blacktown Hospital
Blacktown, New South Wales, Australia
NOT_YET_RECRUITINGScientia Clinical Research
Randwick, New South Wales, Australia
NOT_YET_RECRUITINGGenesisCare St Leonards, 7 Westbourne St, St Leonards
Sydney, New South Wales, Australia
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
RP2D
Determination of RP2D in the expansion phase
Time frame: up to 2 tears
ORR
Further expand the inclusion to clarify the efficacy endpoint ORR
Time frame: up to 3 tears
Cmax
Maximum Observed Blood Concentration (Cmax) of BPI-572270
Time frame: up to 15 weeks
AUC
Area Under Blood Concentration Time Curve (AUC) of BPI-572270
Time frame: up to 15 weeks
Disease Control Rate (DCR)
Time frame: up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia
NOT_YET_RECRUITINGWarringal Private Hospital
Heidelberg, Victoria, Australia
NOT_YET_RECRUITINGLinear Clinical Research Ltd
Nedlands, Western Australia, Australia
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITING