A Study of BPI-452080 in Subjects With Solid Tumors

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05843305

Collaborator

(none)

Enrollment

Locations

Arms

30.1

Anticipated Duration (Months)

17.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Renal Cell Carcinoma Von Hippel-Lindau Disease	Drug: BPI-452080	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors

Anticipated Study Start Date :

Apr 28, 2023

Anticipated Primary Completion Date :

Mar 25, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation 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.	Drug: BPI-452080 Subjects will receive BPI-452080 until disease progression
Experimental: Dose Expansion 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	Drug: BPI-452080 Subjects will receive BPI-452080 until disease progression

Arm

Intervention/Treatment

Experimental: Dose Escalation

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.

Drug: BPI-452080

Subjects will receive BPI-452080 until disease progression

Experimental: Dose Expansion

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

Drug: BPI-452080

Subjects will receive BPI-452080 until disease progression

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	201321
2	West China Hospital of Sichuan University	Chengdu		China	610041
3	Zhejiang Cancer Hospital	Hangzhou		China	310000
4	Hunan Cancer Hospital	Hunan		China	410031
5	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan		China	430000

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

Principal Investigator: Dingwei Ye, Ph.D, Fudan University
Principal Investigator: Jian Zhang, Ph.D, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05843305

Other Study ID Numbers:

BTP-661811

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Renal Cell

Von Hippel-Lindau Disease

Study Results

No Results Posted as of May 6, 2023