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NCT Number: NCT07124936

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

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HDM2005

Drug

HDM2005 will be administered as an intravenous injection.

Rituximab or rituximab biosimilar

Drug

Rituximab or Rituximab biosimilar will be administered as an intravenous injection.

Gemcitabine

Drug

Gemcitabine will be administered as an intravenous injection.

Oxaliplatin

Drug

Oxaliplatin will be administered as an intravenous injection.

Cyclophosphamide

Drug

Cyclophosphamide will be administered as an intravenous injection.

Doxorubicin

Drug

Doxorubicin will be administered as an intravenous injection.

Prednisone

Drug

Prednisone will be administered orally.

Primary outcomes

  1. Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part

    Time frame: Up to ~3 weeks

    The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for dose-escalation part of this study.

  2. 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

    Incidence and grading of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status score.

  3. Complete response (CR) rate in dose-expansion part

    Time frame: Up to ~30 months

    CR rate is defined as the percentage of participants who achieve a complete response (CR) per Lugano criteria, as determined by the investigator

  4. RP2D of HDM2005

    Time frame: Up to ~30 months

    Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r/r DLBCL and untreated DLBCL

Secondary outcomes

  1. Plasma concentration of HDM2005, total antibody and monomethyl auristatin E (MMAE)

    Time frame: Up to ~30 months

    Plasma concentration of HDM2005, total antibody and MMAE will be reported for each dose level

  2. Number of participants positive for anti-drug antibodies (ADA)

    Time frame: Up to ~30 months

    Number of participants with positive ADA will be assessed

  3. 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

    Incidence and grading of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status score.

  4. Objective response rate (ORR)

    Time frame: Up to ~30 months

    ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria as determined by the investigator

  5. Progression-free survival (PFS)

    Time frame: Up to ~54 months

    PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator

  6. Duration of response (DOR)

    Time frame: Up to ~54 months

    DOR is defined as the interval from the first documentation of CR or PR until disease progression or death due to any cause, whichever occurs first

  7. Time to response (TTR)

    Time frame: Up to ~54 months

    TTR is defined as the interval from the start of study therapy to the first documentation of CR or PR

  8. Time to progression (TTP)

    Time frame: Up to ~54 months

    TTP is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression as determined by the investigator

  9. Overall survival (OS)

    Time frame: Up to ~54 months

    OS is defined as the time from randomization to death due to any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Meiping Kong

CONTACT

[email protected]

+8613735478976

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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