A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341570
• Other study ID #: BTP-661511
• Status: Recruiting
• Phase: Phase 1
• Start date: January 19, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Binghe Xu, Ph.D
• Phone: 010-87788826
• Email: xubinghe[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose expansion phase patients are required to harbor PIK3CA mutation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =70 years, male and female patients;

2. Life expectancy = 12 weeks;

3. ECOG performance score 0-1;

4. Locally advanced or relapsed/metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy or for whom no standard therapy exists, PIK3CA mutation status is required for dose expansion phase;

5. Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;

6. Adequate organ function;

7. Signed informed consent.

Exclusion Criteria:

1. Prior use of PI3K?mTOR or AKT inhibitor;

2. Prior other malignant tumor;

3. Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;

4. Type I or type II diabetes;

5. Inadequate wash-out of prior anti-cancer therapies;

6. Cardiac disorders;

7. Instable systemic diseases;

8. Acute or chronic pancreatitis;

9. Pregnancy or lactation;

10. Other protocol specified criteria.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• BPI-21668
Subjects will receive BPI-21668 until disease progression

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

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	The adverse events (AEs)	Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).	Through the Phase I, approximately 24 months
Primary	Determine the Maximum Tolerated Dose (MTD)	The MTD will be based on DLT.	Through the Phase I, approximately 24 months
Primary	Determine the recommended Phase II dose (RP2D)	The RP2D will be based on DLT.	Through the Phase I, approximately 24 months
Secondary	Evaluate the pharmacokinetics of BPI-21668	Based on blood plasma concentration	Through the Phase I, approximately 24 months
Secondary	Determination of anti-tumor activity of BPI-21668	Efficacy assessments (tumor evaluation) will be performed per RECIST1.1	Through the Phase I, approximately 24 months