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Recruiting NCT07124936

A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma

Phase I / Phase II Interventional Diffuse Large B Cell Lymphoma (DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDM2005, Rituximab or Rituximab biosimilar, Gemcitabine, Oxaliplatin.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma

Overview

The purpose of this phase 1b/2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed/refractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The study will consist of two parts: dose-escalation part and dose-expansion part.

Interventions

  • Drug HDM2005
    HDM2005 will be administered as an intravenous injection.
  • Drug Rituximab or Rituximab biosimilar
    Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
  • Drug Gemcitabine
    Gemcitabine will be administered as an intravenous injection.
  • Drug Oxaliplatin
    Oxaliplatin will be administered as an intravenous injection.
  • Drug Cyclophosphamide
    Cyclophosphamide will be administered as an intravenous injection.
  • Drug Doxorubicin
    Doxorubicin will be administered as an intravenous injection.
  • Drug Prednisone
    Prednisone will be administered orally.

Primary outcome measures

  • Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part [Time frame: Up to ~3 weeks]
  • Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part [Time frame: Up to ~54 months]
  • Complete response (CR) rate in dose-expansion part [Time frame: Up to ~30 months]
  • RP2D of HDM2005 [Time frame: Up to ~30 months]
Secondary outcome measures (9)
  • Plasma concentration of HDM2005, total antibody and monomethyl auristatin E (MMAE) [Time frame: Up to ~30 months]
  • Number of participants positive for anti-drug antibodies (ADA) [Time frame: Up to ~30 months]
  • Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-expansion part [Time frame: Up to ~54 months]
  • Objective response rate (ORR) [Time frame: Up to ~30 months]
  • Progression-free survival (PFS) [Time frame: Up to ~54 months]
  • Duration of response (DOR) [Time frame: Up to ~54 months]
  • Time to response (TTR) [Time frame: Up to ~54 months]
  • Time to progression (TTP) [Time frame: Up to ~54 months]
  • Overall survival (OS) [Time frame: Up to ~54 months]

Eligibility criteria

Inclusion criteria

  • Male or female aged 18-75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy >12 weeks.
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL).

a. Cohort B: International Prognostic Index (IPI) score of 2-5.

  • Prior treatment:
  • Cohort A: At least one (≥1) line of prior systemic therapy.
  • Cohort B: Has received no prior treatment for DLBCL.
  • At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan.
  • Adequate organ system and hematologic function as defined in protocol.

Exclusion criteria

  • Known active central nervous system (CNS) lymphoma.
  • Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • History of severe bleeding disorders.
  • History of interstitial lung disease or radiation pneumonitis.
  • Prior solid organ transplant.
  • Ongoing Grade >1 treatment-related adverse events.
  • Current or history of clinically significant cardiovascular and cerebrovascular diseases.
  • Active infection requiring systemic therapy.
  • Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.
  • Prior ROR1-targeted therapy.
  • Ongoing corticosteroid therapy.
  • Current active autoimmune disease or history of autoimmune disease requiring treatment.
  • History of drug anaphylaxis or severe food allergy.
  • Any history or current evidence of disease, treatment, or laboratory abnormality as determined by the investigator that may affect the study results, interfere with the subject's full participation in the study, or be contrary to the subject's best interests.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 21 centers
  • Peking University Cancer Hospital — Beijing
  • Fujian Cancer Hospital — Fuzhou
  • Sun Yat-sen University Cancer Center — Guangzhou
  • The Affiliated Tumor Hospital of Guangxi Medical University — Nanning
  • Affiliated Tumor Hospital of Harbin Medical University — Harbin
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Henan Cancer Hospital — Zhengzhou
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • … and 13 more centers

Identifiers

NCT: NCT07124936 · HDM2005-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗