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A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas

Primary Purpose

B Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1912
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age greater than or equal to18 years old, male or female;
  2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
  3. Life expectancy >12 weeks;
  4. Histologically or cytologically confirmed B cell lymphoma;
  5. Relapsed and/or refractory disease after at least 1 prior treatment regimen;
  6. At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter (no need for dose escalation stage).

Exclusion Criteria:

  1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
  2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
  3. Received anti-tumour treatment within 2 weeks before the first study treatment;
  4. Central nervous system (CNS) infiltration;
  5. Active infection with HBV or HCV;
  6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
  7. Active infection or unexplained fever>38.5℃;
  8. History of severe cardiovascular disease.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

SHR-A1912

Outcomes

Primary Outcome Measures

Adverse Events
Dose Limited Toxicity (DLT)
Maximum tolerable dose (MTD)
Recommended phase II dose (RP2D)

Secondary Outcome Measures

Adverse Events
Time of maximum observed plasma concentration (Tmax) of SHR-1912
Maximum observed plasma concentration (Cmax) of SHR-1912
Area under the plasma concentration time curve (AUC) of SHR-1912
Anti-drug antibody (ADA) of SHR-A1912
Complete Response Rate (CR)
Objective Response Rate (ORR)
Duration of Response (DoR)
Disease Control Rate (DCR)
Progression-Free Survival (PFS)
Overall Survival (OS)

Full Information

First Posted
November 5, 2021
Last Updated
June 11, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05113069
Brief Title
A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas
Official Title
An Open-Label, Single-Arm, Multicenter, Phase I Study to Estimate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 in Patients With B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical 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
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
single arm for SHR-A1912
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
SHR-A1912
Intervention Type
Drug
Intervention Name(s)
SHR-A1912
Intervention Description
SHR-A1912, dose escalation and expansion.
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
21 Days after the 1st dosing (first cycle)
Title
Dose Limited Toxicity (DLT)
Time Frame
21 Days (first cycle)
Title
Maximum tolerable dose (MTD)
Time Frame
21 Days (first cycle)
Title
Recommended phase II dose (RP2D)
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
12 weeks after the last dose
Title
Time of maximum observed plasma concentration (Tmax) of SHR-1912
Time Frame
21 days after last dose
Title
Maximum observed plasma concentration (Cmax) of SHR-1912
Time Frame
21 days after last dose
Title
Area under the plasma concentration time curve (AUC) of SHR-1912
Time Frame
21 days after last dose
Title
Anti-drug antibody (ADA) of SHR-A1912
Time Frame
12 weeks after last dose
Title
Complete Response Rate (CR)
Time Frame
Up to approximately 2 years
Title
Objective Response Rate (ORR)
Time Frame
Up to approximately 2 years
Title
Duration of Response (DoR)
Time Frame
Up to approximately 2 years
Title
Disease Control Rate (DCR)
Time Frame
Up to approximately 2 years
Title
Progression-Free Survival (PFS)
Time Frame
Up to approximately 2 years
Title
Overall Survival (OS)
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to18 years old, male or female; Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; Life expectancy >12 weeks; Histologically or cytologically confirmed B cell lymphoma; Relapsed and/or refractory disease after at least 1 prior treatment regimen; At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter (no need for dose escalation stage). Exclusion Criteria: Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment; History of recent major surgery or severe trauma within 4 weeks before the first study treatment; Received anti-tumour treatment within 2 weeks before the first study treatment; Central nervous system (CNS) infiltration; Active infection with HBV or HCV; History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis; Active infection or unexplained fever>38.5℃; History of severe cardiovascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenyu Xiao, Ph.D.
Phone
86-021-23511999
Email
zhenyu.xiao.zx7@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shouwei Zhao
Phone
86-010-67166319
Email
shouwei.zhao@hengrui.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, Doctor
Phone
+86-13910333346
Email
zhujun3346@163.com
First Name & Middle Initial & Last Name & Degree
Yuqin Song, Doctor
Phone
+86-13683398726
Email
songyuqin622@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas

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