Solid Tumor Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
Status | Not yet recruiting |
Enrollment | 87 |
Est. completion date | October 31, 2025 |
Est. primary completion date | March 25, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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-2a 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 |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | |
China | Zhejiang Cancer Hospital | Hangzhou | |
China | Hunan Cancer Hospital | Hunan | |
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan |
Lead Sponsor | Collaborator |
---|---|
Betta Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adverse events (AEs) | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events | Through the Phase I, approximately 24 months | |
Secondary | Cmax | Maximum observed concentration | Through the Phase I, approximately 24 months | |
Secondary | Tmax | Time to reach maximum observed plasma concentration | Through the Phase I, approximately 24 months | |
Secondary | t1/2 | Half-life time | Through the Phase I, approximately 24 months | |
Secondary | the objective response rate(ORR) | The proportion of patients with complete response (CR) and partial response (PR) in all patients | Through the Phase I, approximately 24 months | |
Secondary | Progression free survival (PFS) | The time from the date of randomization to disease progression (PD) or death, whichever occurs first | Through the Phase I, approximately 24 months |
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