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

NCT05341570 | Unknown Phase 1

• 1 other identifier: BTP-661511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Evaluate the pharmacokinetics of BPI-21668

  Through the Phase I, approximately 24 months

• Determination of anti-tumor activity of BPI-21668

  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 28 days in duration with BPI-21668 administered, once daily (QD).

Drug: BPI-21668

Dose Expansion

EXPERIMENTAL

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

Interventions

BPI-21668 DRUG

Subjects will receive BPI-21668 until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤70 years, male and female patients;
• Life expectancy ≥ 12 weeks;
• ECOG performance score 0-1;
• 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;
• Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;
• Adequate organ function;
• Signed informed consent.

You may not qualify if:

• Prior use of PI3K、mTOR or AKT inhibitor;
• Prior other malignant tumor;
• Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;
• Type I or type II diabetes;
• Inadequate wash-out of prior anti-cancer therapies;
• Cardiac disorders;
• Instable systemic diseases;
• Acute or chronic pancreatitis;
• Pregnancy or lactation;
• Other protocol specified criteria.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Study Officials

• Binghe Xu, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, Ph.D

CONTACT

010-87788826; xubinghe@csco.org.cn

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 18, 2022
• First Posted: April 22, 2022
• Study Start: January 19, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)