This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed/refractory B-cell lymphoma and advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
HDM2005 will be administered via IV infusion.
Henan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe Second Affiliated Hospital of Soochow University
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Time frame: up to 21 days following first dose
Incident and severity of adverse events(for dose escalation phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
Objective Response Rate (ORR)(for dose expansion phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame: Until withdrawal of consent, loss to follow-up, initiation of other new antineoplastic therapy, end of study, or study termination by the sponsor, whichever occurs first (up to approximately 3.5 years)
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data.
Time frame: Approximately 3.5 years
Plasma concentration of HDM2005, total antibody and the free MMAE
Plasma concentration of HDM2005, total antibody and the free MMAE will be reported for each arm.
Time frame: up to 28 days following last dose
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
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Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGThe Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
Tianjing, China
RECRUITINGTime frame: up to 28 days following last dose
Incident and severity of adverse events(for dose expansion phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Time frame: Approximately 3.5 years
Time to Response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.
Time frame: Approximately 3.5 years
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.
Time frame: Approximately 3.5 years
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.
Time frame: Approximately 3.5 years
Overall survival (OS)
OS is defined as the interval from the start of study therapy to death from any cause.
Time frame: Approximately 3.5 years