HDM2005Rituximab or Rituximab biosimilarGemcitabineOxaliplatinCyclophosphamideDoxorubicinPrednisone
HDM2005: HDM2005 will be administered as an intravenous injection.
Rituximab or Rituximab biosimilar: Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
Gemcitabine: Gemcitabine will be administered as an intravenous injection.
Oxaliplatin: Oxaliplatin will be administered as an intravenous injection.
Cyclophosphamide: Cyclophosphamide will be administered as an intravenous injection.
Doxorubicin: Doxorubicin will be administered as an intravenous injection.
Prednisone: Prednisone will be administered orally.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female aged 18-75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Life expectancy \>12 weeks.
4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
a. Cohort B: International Prognostic Index (IPI) score of 2-5.
5. Prior treatment:
1. Cohort A: At least one (≥1) line of prior systemic therapy.
2. Cohort B: Has received no prior treatment for DLBCL.
6. 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.
7. Adequate organ system and hematologic function as defined in protocol.
Exclusion Criteria:
1. Known active central nervous system (CNS) lymphoma.
2. Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.
3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
4. History of severe bleeding disorders.
5. History of interstitial lung disease or radiation pneumonitis.
6. Prior solid organ transplant.
7. Ongoing Grade \>1 treatment-related adverse events.
8. Current or history of clinically significant cardiovascular and cerebrovascular diseases.
9. Active infection requiring systemic therapy.
10. Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.
11. Prior ROR1-targeted therapy.
12. Ongoing corticosteroid therapy.
13. Current active autoimmune disease or history of autoimmune disease requiring treatment.
14. History of drug anaphylaxis or severe food allergy.
15. 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.
Primary outcome measure(s)
Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part — 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.
Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part — 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.
Complete response (CR) rate in dose-expansion part — 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
RP2D of HDM2005 — Up to ~30 months Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r/r DLBCL and untreated DLBCL
Trial sites (21)
Facility
City
Region
Status
Peking University Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning
Guangxi
Not Yet Recruiting
Affiliated Tumor Hospital of Harbin Medical University
Harbin
Heilongjiang
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
HunanCancer Hospital
Changsha
Hunan
Not Yet Recruiting
Second Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
The first hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Not Yet Recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan
Shandong
Not Yet Recruiting
Shanxi Cancer Hospital
Taiyuan
Shanxi
Not Yet Recruiting
West China Hospital，Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
Active Not Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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