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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BPI-21668

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Binghe Xu, Ph.D; Phone Number: 010-87788826; Email: xubinghe@csco.org.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences
      • Contact: Binghe Xu; Phone Number: 010-87788826; Email: xubinghe@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: BPI-21668; Subjects will receive BPI-21668 until disease progression
Experimental: Dose Expansion; Oral tablets administered at MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).	Drug: BPI-21668; Subjects will receive BPI-21668 until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Determine the Maximum Tolerated Dose (MTD)	The MTD will be based on DLT.	Through the Phase I, approximately 24 months
Determine the recommended Phase II dose (RP2D)	The RP2D will be based on DLT.	Through the Phase I, approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pharmacokinetics of BPI-21668	Based on blood plasma concentration	Through the Phase I, approximately 24 months
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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Binghe Xu, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BTP-661511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No