Clinical trial NCT05843305: A Study of BPI-452080 in Subjects With Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Renal Cell Carcinoma
Von Hippel-Lindau Disease
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors


Eligibility criteria: 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

Primary outcomes:
measure: adverse events (AEs)
timeFrame: Through the Phase I, approximately 24 months
Secondary outcomes:
measure: Cmax
timeFrame: Through the Phase I, approximately 24 months
measure: Tmax
timeFrame: Through the Phase I, approximately 24 months
measure: t1/2
timeFrame: Through the Phase I, approximately 24 months
measure: the objective response rate（ORR）
timeFrame: Through the Phase I, approximately 24 months
measure: Progression free survival (PFS)
timeFrame: Through the Phase I, approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hunan
country: China
facility: Hunan Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
Study officials:
affiliation: Fudan University
name: Dingwei Ye, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jian Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: