A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas

NCT05113069 | Unknown Phase 1

• 1 other identifier: SHR-A1912-I-101
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  21 Days after the 1st dosing (first cycle)

• Dose Limited Toxicity (DLT)

  21 Days (first cycle)

• Maximum tolerable dose (MTD)

  21 Days (first cycle)

• Recommended phase II dose (RP2D)

  Up to approximately 2 years

Secondary Outcomes (11)

• Adverse Events

  12 weeks after the last dose

• Time of maximum observed plasma concentration (Tmax) of SHR-1912

  21 days after last dose

• Maximum observed plasma concentration (Cmax) of SHR-1912

  21 days after last dose

• Area under the plasma concentration time curve (AUC) of SHR-1912

  21 days after last dose

• Anti-drug antibody (ADA) of SHR-A1912

  12 weeks after last dose

Study Arms (1)

Treatment group

EXPERIMENTAL

SHR-A1912

Drug: SHR-A1912

Interventions

SHR-A1912 DRUG

SHR-A1912, dose escalation and expansion.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to18 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
• Life expectancy \>12 weeks;
• Histologically or cytologically confirmed B cell lymphoma;
• Relapsed and/or refractory disease after at least 1 prior treatment regimen;
• 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).

You may not qualify if:

• 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;
• History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
• Received anti-tumour treatment within 2 weeks before the first study treatment;
• Central nervous system (CNS) infiltration;
• Active infection with HBV or HCV;
• History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
• Active infection or unexplained fever\>38.5℃;
• History of severe cardiovascular disease.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm for SHR-A1912

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: December 22, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 30, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CN (1)