This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
HDM2005 will be administered via IV infusion.
Fudan University shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence 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 or 28 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.
Progression-free survival(PFS)(for dose expansion phase)
PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1.
Time frame: Approximately 30 months
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: Approximately 18 months
Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) 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. The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic and efficacy data.
Time frame: Approximately 30 months
Plasma concentration of HDM2005, total antibody and the free MMAE
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: up to 28 days following last dose
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 18 months
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 30 months
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 30 months
Overall survival (OS)
OS is defined as the interval from the start of study therapy to death from any cause.
Time frame: Approximately 30 months