HMPL-A251 for Cancer

Not yet recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hutchmed

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Type I diabetes, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called HMPL-A251, a potential cancer therapy, for individuals with certain types of advanced cancer that cannot be surgically removed. The primary goal is to evaluate the treatment's effectiveness and determine the optimal dose. Participants will be divided into groups to test different doses or optimize the treatment. Suitable candidates for this trial are those with advanced, non-resectable cancer and tumors that test positive for HER2, a specific protein. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, especially strong inhibitors of specific enzymes and proteins, at least 2 weeks before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that HMPL-A251 is likely to be safe for humans?

Research has shown that HMPL-A251 has been promising in early tests. In lab studies, it successfully stopped the growth of HER2-positive cancer cells. It also performed well in animal studies, demonstrating strong anti-tumor effects and good tolerance.

However, since HMPL-A251 remains in the early stages of human trials, safety information for people is limited. This means there is still uncertainty about how well humans can handle this treatment. The first stage of human testing focuses on ensuring safety and determining the right dose, with close monitoring for any side effects.

Prospective participants should discuss potential risks and benefits with the research team. They can provide more specific information based on the latest findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HMPL-A251 because it offers a novel approach to treating cancer. Unlike standard treatments like chemotherapy and radiation, HMPL-A251 works by targeting specific cancer cell pathways, potentially leading to more precise and less toxic effects. This treatment aims to optimize dosage for maximum effectiveness with minimal side effects, setting it apart from traditional therapies that often come with significant adverse reactions. By focusing on dose escalation and optimization, HMPL-A251 has the potential to improve outcomes for patients in a way that current options may not.

What evidence suggests that HMPL-A251 might be an effective treatment for cancer?

Research has shown that HMPL-A251 may help treat certain solid tumors with the HER2 protein. In lab studies, it effectively stopped the growth of these tumor cells. This treatment specifically targets HER2, which aids cancer growth, making it particularly useful for these tumors. In animal studies, HMPL-A251 performed better and was gentler on the body than similar treatments lacking this specific targeting. These early results suggest that HMPL-A251 could be a strong option for patients with HER2-positive cancers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that express the HER2 protein and cannot be removed by surgery. Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have tried other treatments first.

Inclusion Criteria

Have at least one measurable lesion per RECIST v1.1

Life expectancy ≥ 12 weeks

I weigh at least 35 kg.

Exclusion Criteria

Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant

I have been diagnosed with type I diabetes or my type II diabetes is not under control.

I haven't taken strong inhibitors that affect drug metabolism or transport recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of HMPL-A251 to determine the maximum tolerated dose (MTD)

Approximately 12 months

Dose Expansion/Dose Optimization

Participants receive HMPL-A251 at recommended doses for expansion to evaluate safety and preliminary efficacy

Approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 24 months

What Are the Treatments Tested in This Trial?

Interventions

• HMPL-A251

Trial Overview The study is testing HMPL-A251, a new therapy for cancer. It's an open-label trial, meaning both researchers and participants know what treatment is being given. The phase I/IIa stages indicate it's early in testing, focusing on safety and effectiveness.

How Is the Trial Designed?

Group I: Part B(Phase IIa) Experimental Treatment 1 Intervention

Dose Expansion/Dose Optimization

Group II: Part A(Phase I) Experimental Treatment 1 Intervention

Dose Escalation

Who Is Running the Clinical Trial?

Hutchmed

Lead Sponsor

Trials

38

Recruited

6,700+

Citations

1. biospace.com biospace.com/press-releases/hutchmed-highlights-hmpl-a251-data-presented-at-the-aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics

HUTCHMED Highlights HMPL-A251 Data Presented at the ... In vivo, HMPL-A251 demonstrated superior anti-tumor efficacy and tolerability as compared to the naked antibody and payload administered ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07228247?aggFilters=status%3A%2CfunderType%3Aindustry

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.

3. globenewswire.com globenewswire.com/news-release/2025/10/23/3171612/0/en/HUTCHMED-Highlights-HMPL-A251-Data-Presented-at-the-AACR-NCI-EORTC-International-Conference-on-Molecular-Targets-and-Cancer-Therapeutics.html

HUTCHMED Highlights HMPL-A251 Data Presented at the HMPL-A251 demonstrated HER2-dependent antitumor activity in vitro, potently inhibiting HER2-positive tumor cell growth regardless of PAM pathway ...

4. trial.medpath.com trial.medpath.com/news/d6bd009c4efbf16f/hutchmed-unveils-first-in-class-hmpl-a251-antibody-targeted-therapy-conjugate-with-superior-efficacy-against-her2-positive-cancers

HUTCHMED Unveils First-in-Class HMPL-A251 Antibody ... HMPL-A251 showed robust antitumor activity across 130 tumor cell lines with synergistic and bystander killing effects, and plasma exposure of ...

5. bioworld.com bioworld.com/articles/725997-hmpl-a251-combines-her2-targeting-with-precision-payload

HMPL-A251 combines HER2 targeting with precision ... In vivo, HMPL-A251 exhibited enhanced antitumor efficacy and tolerability compared to the naked antibody and payload combination.

6. ctv.veeva.com ctv.veeva.com/study/a-phase-i-iia-study-of-hmpl-a251-in-participants-with-advanced-or-metastatic-her2-expressing-solid-tu?comeFrom=%7B%22type%22%3A%22site%22%2C%22slug%22%3A%22brcr-medical-center-plantation-fl%22%7D

A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With ... This is a first-in-human (FIH), phase Ⅰ/Ⅱa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with ...

7. hutch-med.com hutch-med.com/?p=0

HUTCHMED Announces that Fruquintinib Global Phase III ... HMPL-A251 demonstrated HER2-dependent antitumor activity, with potent inhibition of HER2-positive tumor cell growth regardless of PAM pathway alterations, and ...