A Phase 1/2 interventional study of HMPL-A830 and HMPL-A830 in Solid Tumor, Adult, sponsored by Hutchmed. Recruiting at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Hutchmed · Phase 1/2, Interventional, and Treatment
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.
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
Hutchmed is the lead sponsor of 50 studies on the registry; 11 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: HMPL-A830
Drug: HMPL-A830
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
DLTs
Number of Participants With of DLTs
Time frame: Approximately 12 months
Overview of Treatment-emergent Adverse Events (TEAEs)
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: Approximately 12 months
Objective Response Rate (ORR)
Assessed by investigators according to RECIST 1.1
Time frame: Approximately 24 months
Recommended doses for phase II or III studies (RP2D or RP3D)
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 12 months
Disease control rate (DCR)
The DCR by RECIST 1.1
Time frame: Approximately 2 years
Progression-free survival (PFS)
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
Pharmacokinetic Analysis(Cmax)
Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Pharmacokinetic Analysis (Cmin)
Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Pharmacokinetic Analysis(Tmax)
Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Time frame: Approximately 2 years
Pharmacokinetic Analysis((AUClast)
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
Pharmacokinetic Analysis((AUCtau)
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
Incidence of anti-drug antibodies (ADAs) against HMPL-A830
Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.
Time frame: Approximately 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hutchmed