A Study of BPI-452080 in Subjects With Solid Tumors

NCT05843305 | Unknown Phase 1

• 1 other identifier: BTP-661811
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax

  Through the Phase I, approximately 24 months

• Tmax

  Through the Phase I, approximately 24 months

• t1/2

  Through the Phase I, approximately 24 months

• the objective response rate（ORR）

  Through the Phase I, approximately 24 months

• Progression free survival (PFS)

  Through the Phase I, approximately 24 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Dose Expansion

EXPERIMENTAL

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

Interventions

BPI-452080 DRUG

Subjects will receive BPI-452080 until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (5)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310000, China

Location

Hunan Cancer Hospital

Hunan, 410031, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; von Hippel-Lindau Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Vascular Diseases; Cardiovascular Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Dingwei Ye, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian Zhang, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingwei Ye, Ph.D

CONTACT

13701663571; fuscc2012@163.com

Jian Zhang, Ph.D

CONTACT

13918273761; Syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: April 28, 2023
• Primary Completion: March 25, 2025
• Study Completion: October 31, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

CN (5)