A Phase 1 Study of BPI-371153 in Subjects With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Primary Purpose
Advanced Solid Tumor, Lymphoma, NSCLC
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BPI-371153
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic Non-Driver Mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);
- Adequate organ function;
Exclusion Criteria:
- Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;
- Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;
- Prior other specific T cell targeting agents;
- Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment.
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;
- Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
- Pregnancy or lactation;
- Other conditions considered not appropriate to participate in this trial by the investigators.
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Cangzhou Central Hospital
- Tianjin Cancer Hospital
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation
Dose Expansion
Arm Description
Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).
Oral capsules administered at recommended doses. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD). Cohort 1: Advanced NSCLC Cohort 2: Relapsed/refractory lymphoma Cohort 3: Advanced HCC Cohort 4: Other Advanced Solid Tumors
Outcomes
Primary Outcome Measures
The adverse events (AEs)
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs)
Determine the recommended Phase II dose (RP2D)
Number of subjects with dose limiting toxicity
Secondary Outcome Measures
Evaluate the pharmacokinetics of BPI-371153
Based on blood plasma concentration
Determination of anti-tumor activity of BPI-371153
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1, mRECIST or Lugano 2014 depending on tumor type.
To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity
Based on the levels of expression of PD-L1 and anti-tumor activity of BPI-371153
Full Information
NCT ID
NCT05341557
First Posted
April 18, 2022
Last Updated
June 15, 2022
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05341557
Brief Title
A Phase 1 Study of BPI-371153 in Subjects With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Official Title
A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-371153 in Subjects With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Lymphoma, NSCLC, HCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Oral capsules administered at recommended doses. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).
Cohort 1: Advanced NSCLC Cohort 2: Relapsed/refractory lymphoma Cohort 3: Advanced HCC Cohort 4: Other Advanced Solid Tumors
Intervention Type
Drug
Intervention Name(s)
BPI-371153
Intervention Description
Subjects will receive BPI-371153 until disease progression
Primary Outcome Measure Information:
Title
The adverse events (AEs)
Description
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs)
Time Frame
Through the Phase I, approximately 24 months
Title
Determine the recommended Phase II dose (RP2D)
Description
Number of subjects with dose limiting toxicity
Time Frame
Through the Phase I, approximately 24 months
Secondary Outcome Measure Information:
Title
Evaluate the pharmacokinetics of BPI-371153
Description
Based on blood plasma concentration
Time Frame
Through the Phase I, approximately 24 months
Title
Determination of anti-tumor activity of BPI-371153
Description
Efficacy assessments (tumor evaluation) will be performed per RECIST1.1, mRECIST or Lugano 2014 depending on tumor type.
Time Frame
Through the Phase I, approximately 24 months
Title
To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity
Description
Based on the levels of expression of PD-L1 and anti-tumor activity of BPI-371153
Time Frame
Through the Phase I, approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic Non-Driver Mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);
Adequate organ function;
Exclusion Criteria:
Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;
Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;
Prior other specific T cell targeting agents;
Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment.
Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;
Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
Pregnancy or lactation;
Other conditions considered not appropriate to participate in this trial by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, Ph.D
Phone
010-67781331
Email
syuankaipumc@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Chaoyang
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Ph.D
Phone
010-67781331
Email
syuankaipumc@126.com
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
062650
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinghua Zhang, Ph.D
Email
zhangjinghuazlnk@163.com
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, Ph.D
Phone
022-23340123
Email
rwziyi@yahoo.com
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong, Ph.D
Phone
022-60817009
Email
zhongdsh@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 1 Study of BPI-371153 in Subjects With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
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