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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
The first hospital of Jilin University
NOT_YET_RECRUITING
Changchun
HunanCancer Hospital
NOT_YET_RECRUITING
Changsha
West China Hospital，Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Affiliated Tumor Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
NOT_YET_RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University
ACTIVE_NOT_RECRUITING
Kunming
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Affiliated Tumor Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITING
Shenyang
Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Meiping Kong
cxykongmeiping@eastchinapharm.com
+8613735478976
Time Frame
Start Date:2025-07-30
Estimated Completion Date:2029-10-25
Participants
Target number of participants:97
Treatments
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.