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

A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: B-cell Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: SHR-A1912; R-Chemo; Drug: SHR-A1912; R-Chemo

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhenyu Xiao, Medical Director; Phone Number: 021-61053363; Email: zhenyu.xiao.zx7@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Yuqin Song, Doctor; Phone Number: +86-13683398726; Email: songyuqin622@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A1912 combined with R-Chemo (Phase 1b)	Drug: SHR-A1912; R-Chemo; SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b); Drug: SHR-A1912; R-Chemo; SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)
Experimental: SHR-A1912 combined with R-Chemo (Phase 2)	Drug: SHR-A1912; R-Chemo; SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b); Drug: SHR-A1912; R-Chemo; SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: SHR-A1912-II-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No