A Study of BPI-452080 in Subjects With Solid Tumors

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843305
• Other study ID #: BTP-661811
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 28, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2023
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Dingwei Ye, Ph.D
• Phone: 13701663571
• Email: fuscc2012[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma
• Solid Tumor
• Von Hippel-Lindau Disease

Intervention

Drug:
• BPI-452080
Subjects will receive BPI-452080 until disease progression

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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