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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06104553
Other study ID # SHR-A1912-II-201
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 17, 2023
Est. completion date June 2026

Study information

Verified date December 2023
Source Shanghai Hengrui Pharmaceutical Co., Ltd.
Contact Zhenyu Xiao, Medical Director
Phone 021-61053363
Email zhenyu.xiao.zx7@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age greater than or equal to18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy >3 months; 4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma; 5. Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (= 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort). 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. 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


Related Conditions & MeSH terms


Intervention

Drug:
SHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
SHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)

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 Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Primary Phase 1b: Incidence and severity of AE Up to follow-up period, approximately 24 months]
Primary Phase 2: Objective response rate assessed up to approximately 24 months
Secondary Phase 1b: Objective response rate assessed up to approximately 24 months
Secondary Phase 1b: Complete response rate (CRR) assessed up to approximately 24 months
Secondary Phase 1b: Duration of remission (DoR) assessed up to approximately 24 months
Secondary Phase 1b: Progression-free survival (PFS) assessed up to approximately 24 months
Secondary Phase 1b: Toxin binding antibody to SHR-A1912 Up to follow-up period, approximately 24 months
Secondary Phase 1b: Total antibody to SHR-A1912 Up to follow-up period, approximately 24 months
Secondary Phase 1b: Concentration of free toxin Up to follow-up period, approximately 24 months
Secondary Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912 Up to follow-up period, approximately 24 months
Secondary Phase 2: Complete response rate (CRR) assessed up to approximately 24 months
Secondary Phase 2: Duration of remission (DoR) assessed up to approximately 24 months
Secondary Phase 2: Progression-free survival (PFS) assessed up to approximately 24 months
Secondary Phase 2: Incidence and severity of AE Up to follow-up period, approximately 24 months
Secondary Phase 2: Toxin binding antibody to SHR-A1912 Up to follow-up period, approximately 24 months
Secondary Phase 2: Total antibody to SHR-A1912 Up to follow-up period, approximately 24 months
Secondary Phase 2: Concentration of free toxin Up to follow-up period, approximately 24 months
Secondary Phase 2: Anti-drug antibodies (ADA) to SHR-A1912 Up to follow-up period, approximately 24 months
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