NCT06104553

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
1mo left

Started Nov 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

November 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

October 23, 2023

Last Update Submit

December 20, 2023

Conditions

B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

SHR-A1912 combined with R-Chemo (Phase 1b)

EXPERIMENTAL
Drug: SHR-A1912; R-Chemo

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

EXPERIMENTAL
Drug: SHR-A1912; R-Chemo

Interventions

SHR-A1912; R-ChemoDRUG

SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)

SHR-A1912 combined with R-Chemo (Phase 1b)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
  • Life expectancy \>3 months;
  • Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
  • 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).
  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Zhenyu Xiao, Medical Director

CONTACT

021-61053363zhenyu.xiao.zx7@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

November 17, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

CN(1)