A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma

Phase 1

Recruiting

• Conditions: B-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: SHR-A1912; R-Chemo

• Registration Number: NCT06104553
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Study Start: 2023-11-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-A1912 combined with R-Chemo (Phase 2)	SHR-A1912; R-Chemo	-
SHR-A1912 combined with R-Chemo (Phase 1b)	SHR-A1912; R-Chemo	-

Primary Outcome Measures

Name	Time	Method
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
Phase 1b: Incidence and severity of AE	Up to follow-up period, approximately 24 months]
Phase 2: Objective response rate	assessed up to approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Phase 2: Complete response rate (CRR)	assessed up to approximately 24 months
Phase 1b: Objective response rate	assessed up to approximately 24 months
Phase 1b: Complete response rate (CRR)	assessed up to approximately 24 months
Phase 1b: Duration of remission (DoR)	assessed up to approximately 24 months
Phase 1b: Progression-free survival (PFS)	assessed up to approximately 24 months
Phase 1b: Total antibody to SHR-A1912	Up to follow-up period, approximately 24 months
Phase 2: Duration of remission (DoR)	assessed up to approximately 24 months
Phase 2: Concentration of free toxin	Up to follow-up period, approximately 24 months
Phase 1b: Toxin binding antibody to SHR-A1912	Up to follow-up period, approximately 24 months
Phase 1b: Concentration of free toxin	Up to follow-up period, approximately 24 months
Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912	Up to follow-up period, approximately 24 months
Phase 2: Total antibody to SHR-A1912	Up to follow-up period, approximately 24 months
Phase 2: Incidence and severity of AE	Up to follow-up period, approximately 24 months
Phase 2: Progression-free survival (PFS)	assessed up to approximately 24 months
Phase 2: Toxin binding antibody to SHR-A1912	Up to follow-up period, approximately 24 months
Phase 2: Anti-drug antibodies (ADA) to SHR-A1912	Up to follow-up period, approximately 24 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China