Renal Cell Carcinoma, Solid Tumor, Von Hippel-Lindau Disease
Conditions
Brief summary
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
Interventions
DRUGBPI-452080
Subjects will receive BPI-452080 until disease progression
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists * Dose expansion phase: Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors * Adequate organ function * Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase
Exclusion criteria
* Has received prior treatment with another HIF-2α inhibitor * Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc * Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events (AEs) | Through the Phase I, approximately 24 months | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Through the Phase I, approximately 24 months | Maximum observed concentration |
| Tmax | Through the Phase I, approximately 24 months | Time to reach maximum observed plasma concentration |
| t1/2 | Through the Phase I, approximately 24 months | Half-life time |
| the objective response rate（ORR） | Through the Phase I, approximately 24 months | The proportion of patients with complete response (CR) and partial response (PR) in all patients |
| Progression free survival (PFS) | Through the Phase I, approximately 24 months | The time from the date of randomization to disease progression (PD) or death, whichever occurs first |
Countries
China
Contacts
Primary ContactDingwei Ye, Ph.D
Backup ContactJian Zhang, Ph.D
Outcome results
None listed