HMPL-A830
DrugEnrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6
predefined dose levels
NCT Number: NCT07718581
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Beijing Cancer Hospital, Beijing, China
Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.
Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6
predefined dose levels
Time frame: Approximately 12 months
Number of Participants With of DLTs
Time frame: Approximately 12 months
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: Approximately 24 months
Assessed by investigators according to RECIST 1.1
Time frame: Approximately 12 months
The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.
Time frame: Approximately 2 years
The DCR by RECIST 1.1
Time frame: Approximately 2 years
The time from the first dose of study drug to the date of first radiographic PD per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Approximately 2 years
Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.
Hutchmed
Industry
A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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