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.

Trial Details

NCT ID
NCT07124936
Phase
PHASE1 / PHASE2
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • HDM2005
  • Rituximab or Rituximab biosimilar
  • Gemcitabine
  • Oxaliplatin
  • Cyclophosphamide
  • Doxorubicin
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Nanning, Guangxi, China|22.81667,108.31667
  • Harbin, Heilongjiang, China|45.75,126.65

Key Eligibility 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).

For full eligibility, visit ClinicalTrials.gov.

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