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

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05113069
Collaborator
(none)
123
Enrollment
1
Location
1
Arm
30.3
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
123 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single arm for SHR-A1912single arm for SHR-A1912
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 22, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

SHR-A1912

Drug: SHR-A1912
SHR-A1912, dose escalation and expansion.

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [21 Days after the 1st dosing (first cycle)]

  2. Dose Limited Toxicity (DLT) [21 Days (first cycle)]

  3. Maximum tolerable dose (MTD) [21 Days (first cycle)]

  4. Recommended phase II dose (RP2D) [Up to approximately 2 years]

Secondary Outcome Measures

  1. Adverse Events [12 weeks after the last dose]

  2. Time of maximum observed plasma concentration (Tmax) of SHR-1912 [21 days after last dose]

  3. Maximum observed plasma concentration (Cmax) of SHR-1912 [21 days after last dose]

  4. Area under the plasma concentration time curve (AUC) of SHR-1912 [21 days after last dose]

  5. Anti-drug antibody (ADA) of SHR-A1912 [12 weeks after last dose]

  6. Complete Response Rate (CR) [Up to approximately 2 years]

  7. Objective Response Rate (ORR) [Up to approximately 2 years]

  8. Duration of Response (DoR) [Up to approximately 2 years]

  9. Disease Control Rate (DCR) [Up to approximately 2 years]

  10. Progression-Free Survival (PFS) [Up to approximately 2 years]

  11. Overall Survival (OS) [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Hengrui Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05113069
Other Study ID Numbers:
  • SHR-A1912-I-101
First Posted:
Nov 9, 2021
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell

Study Results

No Results Posted as of Apr 18, 2022