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

B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05113069
• Other study ID #: SHR-A1912-I-101
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: December 22, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: November 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 170
• Est. completion date: March 30, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		21 Days after the 1st dosing (first cycle)
Primary	Dose Limited Toxicity (DLT)		21 Days (first cycle)
Primary	Maximum tolerable dose (MTD)		21 Days (first cycle)
Primary	Recommended phase II dose (RP2D)		Up to approximately 2 years
Secondary	Adverse Events		12 weeks after the last dose
Secondary	Time of maximum observed plasma concentration (Tmax) of SHR-1912		21 days after last dose
Secondary	Maximum observed plasma concentration (Cmax) of SHR-1912		21 days after last dose
Secondary	Area under the plasma concentration time curve (AUC) of SHR-1912		21 days after last dose
Secondary	Anti-drug antibody (ADA) of SHR-A1912		12 weeks after last dose
Secondary	Complete Response Rate (CR)		Up to approximately 2 years
Secondary	Objective Response Rate (ORR)		Up to approximately 2 years
Secondary	Duration of Response (DoR)		Up to approximately 2 years
Secondary	Disease Control Rate (DCR)		Up to approximately 2 years
Secondary	Progression-Free Survival (PFS)		Up to approximately 2 years
Secondary	Overall Survival (OS)		Up to approximately 3 years