Clinical trial NCT06104553: A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
Official title: A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: B-cell Non-Hodgkin's Lymphoma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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