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

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05341570
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
36.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients
Actual Study Start Date :
Jan 19, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Determine the Maximum Tolerated Dose (MTD) [Through the Phase I, approximately 24 months]

    The MTD will be based on DLT.

  3. Determine the recommended Phase II dose (RP2D) [Through the Phase I, approximately 24 months]

    The RP2D will be based on DLT.

Secondary Outcome Measures

  1. Evaluate the pharmacokinetics of BPI-21668 [Through the Phase I, approximately 24 months]

    Based on blood plasma concentration

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021

Sponsors and Collaborators

  • Betta Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Binghe Xu, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05341570
Other Study ID Numbers:
  • BTP-661511
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 22, 2022