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

Phase 1

• Conditions: B Cell Lymphoma
• Interventions: Drug: SHR-A1912

• Registration Number: NCT05113069
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-09
• Study Start: 2021-12-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	SHR-A1912	SHR-A1912

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks after the last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1912	21 days after last dose
Disease Control Rate (DCR)	Up to approximately 2 years
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
Duration of Response (DoR)	Up to approximately 2 years
Progression-Free Survival (PFS)	Up to approximately 2 years
Objective Response Rate (ORR)	Up to approximately 2 years
Overall Survival (OS)	Up to approximately 3 years
Complete Response Rate (CR)	Up to approximately 2 years

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China