HMPL-A251 for HER2-expressing Solid Tumors
This study is testing a new drug called HMPL-A251 in adults with advanced or metastatic solid tumors that have a specific marker called HER2. This is a first-in-human study, meaning it's one of the first times this drug is being tested in people. The main goals are to find the safest dose of HMPL-A251 and to see how well it is tolerated. Researchers will also look at how effective the drug is. You might be able to join if you are an adult with advanced or metastatic HER2-expressing solid tumors that can be measured, have a good performance status (meaning you can do most daily activities), and meet other health requirements. The study status is currently unclear, and it plans to enroll 147 participants.
- Study design
- This is an open-label, multicenter study, meaning both you and your doctors will know you are receiving HMPL-A251. It is a Phase 1/2a study, which typically involves a smaller number of participants to test safety and dosage.
- What's involved
- You will receive HMPL-A251 as an intravenous (IV) infusion until your disease progresses, you experience side effects that are too difficult to manage, or other study criteria are met.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor treatment-emergent adverse events (side effects) for approximately 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
At a glance
Conditions
Where it's being run
15 sites across 7 statesWho to contact
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What this trial measures
- Maximum Tolerated Dose (MTD)Approximately 12 months
At least three participants will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN) will be used to guide dose escalation and to determine the MTD of HMPL-A251
- Recommended doses for expansion (RDE)Approximately 12 months
The RDE 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, such as chronic toxicities, discontinuations, or withdrawals for toxicity that occur beyond the DLT period; PK data collected at the time of evaluation; Preliminary efficacy data.
- Overview of Treatment-emergent Adverse Events (TEAEs)Approximately 24 months
All TEAEs will be graded according to NCI CTCAE v6.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA).
- Objective Response Rate (ORR)At least 6 weeks post dose of first participant up to approximately 24 months
ORR is defined as the proportion of participants with Best objective response (BOR) of confirmed complete response (CR) or partial response (PR), as per investigator's assessment according to RECIST v1.1.
- Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A251Approximately 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.