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

NCT ID: NCT05341570

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2025-01-31

Brief 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).

Group Type: EXPERIMENTAL

BPI-21668

Intervention Type: DRUG

Subjects will receive BPI-21668 until disease progression

Dose Expansion

Oral tablets administered at MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).

Group Type: EXPERIMENTAL

BPI-21668

Intervention Type: DRUG

Subjects will receive BPI-21668 until disease progression

Interventions

BPI-21668

Subjects will receive BPI-21668 until disease progression

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binghe Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Binghe Xu, Ph.D

Role: CONTACT

xubinghe@csco.org.cn

010-87788826

Facility Contacts

Binghe Xu

Role: primary

xubinghe@csco.org.cn

010-87788826

Other Identifiers

BTP-661511

Identifier Type: -

Identifier Source: org_study_id