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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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B Cell Lymphoma

Intervention / Treatment
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* Drug: SHR-A1912


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single arm for SHR-A1912
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>SHR-A1912 | Drug: SHR-A1912<br>* SHR-A1912, dose escalation and expansion.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Objective Response Rate (ORR) |  | Up to approximately 2 years | 
| Duration of Response (DoR) |  | Up to approximately 2 years | 
| Disease Control Rate (DCR) |  | Up to approximately 2 years | 
| Progression-Free Survival (PFS) |  | Up to approximately 2 years | 
| Overall Survival (OS) |  | Up to approximately 3 years |