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A Study of BPI-452080 in Subjects With Solid Tumors

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BPI-452080
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer Center
  • West China Hospital of Sichuan University
  • Zhejiang Cancer Hospital
  • Hunan Cancer Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation

Dose Expansion

Arm Description

Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.

Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors

Outcomes

Primary Outcome Measures

adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events

Secondary Outcome Measures

Cmax
Maximum observed concentration
Tmax
Time to reach maximum observed plasma concentration
t1/2
Half-life time
the objective response rate(ORR)
The proportion of patients with complete response (CR) and partial response (PR) in all patients
Progression free survival (PFS)
The time from the date of randomization to disease progression (PD) or death, whichever occurs first

Full Information

First Posted
April 12, 2023
Last Updated
April 24, 2023
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05843305
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 28, 2023 (Anticipated)
Primary Completion Date
March 25, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors
Intervention Type
Drug
Intervention Name(s)
BPI-452080
Intervention Description
Subjects will receive BPI-452080 until disease progression
Primary Outcome Measure Information:
Title
adverse events (AEs)
Description
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
Time Frame
Through the Phase I, approximately 24 months
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum observed concentration
Time Frame
Through the Phase I, approximately 24 months
Title
Tmax
Description
Time to reach maximum observed plasma concentration
Time Frame
Through the Phase I, approximately 24 months
Title
t1/2
Description
Half-life time
Time Frame
Through the Phase I, approximately 24 months
Title
the objective response rate(ORR)
Description
The proportion of patients with complete response (CR) and partial response (PR) in all patients
Time Frame
Through the Phase I, approximately 24 months
Title
Progression free survival (PFS)
Description
The time from the date of randomization to disease progression (PD) or death, whichever occurs first
Time Frame
Through the Phase I, approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingwei Ye, Ph.D
Phone
13701663571
Email
fuscc2012@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang, Ph.D
Phone
13918273761
Email
Syner2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Zhang, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, Ph.D
Phone
13701663571
Email
fuscc2012@163.com
First Name & Middle Initial & Last Name & Degree
Jian Zhang, Ph.D
Phone
13918273761
Email
Syner2000@163.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenhua Liu
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyu Fang
Facility Name
Hunan Cancer Hospital
City
Hunan
ZIP/Postal Code
410031
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusuan Jiang
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Zhang

12. IPD Sharing Statement

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A Study of BPI-452080 in Subjects With Solid Tumors

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