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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
HDM2005 will be administered as an intravenous injection.
Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
Gemcitabine will be administered as an intravenous injection.
Oxaliplatin will be administered as an intravenous injection.
Cyclophosphamide will be administered as an intravenous injection.
Doxorubicin will be administered as an intravenous injection.
Prednisone will be administered orally.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part
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.
Time frame: Up to ~3 weeks
Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part
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.
Time frame: Up to ~54 months
Complete response (CR) rate in dose-expansion part
CR rate is defined as the percentage of participants who achieve a complete response (CR) per Lugano criteria, as determined by the investigator
Time frame: Up to ~30 months
RP2D of HDM2005
Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r/r DLBCL and untreated DLBCL
Time frame: Up to ~30 months
Plasma concentration of HDM2005, total antibody and monomethyl auristatin E (MMAE)
Plasma concentration of HDM2005, total antibody and MMAE will be reported for each dose level
Time frame: Up to ~30 months
Number of participants positive for anti-drug antibodies (ADA)
Number of participants with positive ADA will be assessed
Time frame: Up to ~30 months
Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-expansion part
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.
Time frame: Up to ~54 months
Objective response rate (ORR)
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria as determined by the investigator
Time frame: Up to ~30 months
Progression-free survival (PFS)
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator
Time frame: Up to ~54 months
Duration of response (DOR)
DOR is defined as the interval from the first documentation of CR or PR until disease progression or death due to any cause, whichever occurs first
Time frame: Up to ~54 months
Time to response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of CR or PR
Time frame: Up to ~54 months
Time to progression (TTP)
TTP is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression as determined by the investigator
Time frame: Up to ~54 months
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause
Time frame: Up to ~54 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunanCancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITING...and 11 more locations