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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BPI-21668

• Registration Number: NCT05341570
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Status Verified: 2022-03
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Primary Completion: 2024-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Determine the Maximum Tolerated Dose (MTD)	Through the Phase I, approximately 24 months	The MTD will be based on DLT.
The 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 (AEs).
Determine the recommended Phase II dose (RP2D)	Through the Phase I, approximately 24 months	The RP2D will be based on DLT.

Secondary Outcome Measures

Name	Time	Method
Determination of anti-tumor activity of BPI-21668	Through the Phase I, approximately 24 months	Efficacy assessments (tumor evaluation) will be performed per RECIST1.1
Evaluate the pharmacokinetics of BPI-21668	Through the Phase I, approximately 24 months	Based on blood plasma concentration

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China