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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: B Cell Lymphoma
• Intervention / Treatment: Drug: SHR-A1912

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; SHR-A1912	Drug: SHR-A1912; SHR-A1912, dose escalation and expansion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Limited Toxicity (DLT)	21 Days (first cycle)
Maximum tolerable dose (MTD)	21 Days (first cycle)
Adverse Events	21 Days after the 1st dosing (first cycle)
Recommended phase II dose (RP2D)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to approximately 2 years
Overall Survival (OS)	Up to approximately 3 years
Duration of Response (DoR)	Up to approximately 2 years
Progression-Free Survival (PFS)	Up to approximately 2 years
Adverse Events	12 weeks after the last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1912	21 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1912	21 days after last dose
Area under the plasma concentration time curve (AUC) of SHR-1912	21 days after last dose
Anti-drug antibody (ADA) of SHR-A1912	12 weeks after last dose
Complete Response Rate (CR)	Up to approximately 2 years
Disease Control Rate (DCR)	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: SHR-A1912-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No