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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07124936
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 15, 2025
Start date
Jul 30, 2025
Status verified
Aug 2025
Primary completion
Oct 26, 2027
Completion
Oct 25, 2029

Study Design

Enrollment
97 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with r/r DLBCL (Cohort A)
    Participants with r/r DLBCL will receive a dose of HDM2005 (1.8 mg/kg or 2.0 mg/kg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8) plus 1000 mg/ m\^2 gemcitabine (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8), 100 mg/ m\^2 oxaliplatin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6-8 cycles.
  • Experimental: Participants with untreated DLBCL (Cohort B)
    Participants with untreated DLBCL will receive a dose of HDM2005 (1.8 mg/kg or 2.0 mg/kg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6) plus 750 mg/m\^2 cyclophosphamide (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), 50 mg/m\^2 doxorubicin (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 and 2 Cycle 1 and Day 1 Cycle 2 to 6 of each 3-week cycle for up to 6 cycles. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles.

Primary Outcome Measure

Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part [ Time Frame: Up to ~3 weeks ]

Central Contacts

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