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
Apply to this trial

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

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

Related Studies