Clinical trial NCT05113069: A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: B Cell Lymphoma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm for SHR-A1912
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 21 Days after the 1st dosing (first cycle)
measure: Dose Limited Toxicity (DLT)
timeFrame: 21 Days (first cycle)
measure: Maximum tolerable dose (MTD)
timeFrame: 21 Days (first cycle)
measure: Recommended phase II dose (RP2D)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 weeks after the last dose
measure: Time of maximum observed plasma concentration (Tmax) of SHR-1912
timeFrame: 21 days after last dose
measure: Maximum observed plasma concentration (Cmax) of SHR-1912
timeFrame: 21 days after last dose
measure: Area under the plasma concentration time curve (AUC) of SHR-1912
timeFrame: 21 days after last dose
measure: Anti-drug antibody (ADA) of SHR-A1912
timeFrame: 12 weeks after last dose
measure: Complete Response Rate (CR)
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: