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

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104553
Collaborator
(none)
132
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR-A1912; R-Chemo
  • Drug: SHR-A1912; R-Chemo
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trialAn open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

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)
Experimental: SHR-A1912 combined with R-Chemo (Phase 2)

Drug: SHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Phase 1b: Incidence and severity of AE [Up to follow-up period, approximately 24 months]]

  3. Phase 2: Objective response rate [assessed up to approximately 24 months]

Secondary Outcome Measures

  1. Phase 1b: Objective response rate [assessed up to approximately 24 months]

  2. Phase 1b: Complete response rate (CRR) [assessed up to approximately 24 months]

  3. Phase 1b: Duration of remission (DoR) [assessed up to approximately 24 months]

  4. Phase 1b: Progression-free survival (PFS) [assessed up to approximately 24 months]

  5. Phase 1b: Toxin binding antibody to SHR-A1912 [Up to follow-up period, approximately 24 months]

  6. Phase 1b: Total antibody to SHR-A1912 [Up to follow-up period, approximately 24 months]

  7. Phase 1b: Concentration of free toxin [Up to follow-up period, approximately 24 months]

  8. Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912 [Up to follow-up period, approximately 24 months]

  9. Phase 2: Complete response rate (CRR) [assessed up to approximately 24 months]

  10. Phase 2: Duration of remission (DoR) [assessed up to approximately 24 months]

  11. Phase 2: Progression-free survival (PFS) [assessed up to approximately 24 months]

  12. Phase 2: Incidence and severity of AE [Up to follow-up period, approximately 24 months]

  13. Phase 2: Toxin binding antibody to SHR-A1912 [Up to follow-up period, approximately 24 months]

  14. Phase 2: Total antibody to SHR-A1912 [Up to follow-up period, approximately 24 months]

  15. Phase 2: Concentration of free toxin [Up to follow-up period, approximately 24 months]

  16. Phase 2: Anti-drug antibodies (ADA) to SHR-A1912 [Up to follow-up period, approximately 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Hengrui Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06104553
Other Study ID Numbers:
  • SHR-A1912-II-201
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell

Study Results

No Results Posted as of Oct 27, 2023