HMPL-A580 for Cancer

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: Diabetes, Major surgery, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HMPL-A580 for individuals with advanced solid tumors that cannot be surgically removed. The study aims to determine the optimal dose and evaluate the treatment's effectiveness. It consists of two parts: one to establish the correct dose and another to assess its efficacy. Candidates may qualify if they have a solid tumor that has spread or is inoperable and have at least one tumor measurable by doctors. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants the opportunity to be among the first to benefit from this new therapy.

Is there any evidence suggesting that HMPL-A580 is likely to be safe for humans?

Research shows that HMPL-A580 offers a new approach to cancer treatment. As a "first-in-class" therapy, it operates differently from existing treatments by using a special molecule to target specific proteins in cancer cells and an antibody to direct the treatment to the cancer.

Since HMPL-A580 is being tested in humans for the first time, detailed safety information from previous human trials is unavailable. However, reaching phase I/IIa indicates sufficient initial evidence to consider it safe for human testing. Early trials typically begin with low doses, gradually increasing them while monitoring for side effects. This careful approach helps ensure safety.

Although specific side effects have not yet been reported, healthcare professionals closely monitor participants in clinical trials to manage any potential risks promptly. As more data emerges, the safety and tolerability of HMPL-A580 will become clearer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HMPL-A580 because it offers a novel approach to treating cancer. Most current treatments, like chemotherapy and radiation, primarily target rapidly dividing cells, which can lead to significant side effects. HMPL-A580, however, works through a different mechanism by specifically targeting certain pathways involved in cancer cell growth, potentially offering a more precise and less toxic option. This targeted action could lead to better outcomes and fewer side effects for patients, making it a promising new option in the fight against cancer.

What evidence suggests that HMPL-A580 might be an effective treatment for cancer?

Research has shown that HMPL-A580 holds promising potential for treating certain cancers. In lab studies, it successfully stopped the growth of cancer cells with a protein called EGFR, which is linked to cancer growth. This treatment combines a drug that blocks cancer cell signals with another component that targets the cancer cells directly. Studies in mice demonstrated that HMPL-A580 can shrink tumors, with higher doses leading to more significant tumor reduction. These early results suggest that HMPL-A580 could effectively treat cancers that are difficult to manage with current options. Participants in this trial will join either the Phase I dose escalation or the Phase IIa dose expansion/optimization to further evaluate the effectiveness and safety of HMPL-A580. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am fully active or can do light work despite my illness.

I understand the study and can sign the consent form myself.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase I)

Participants receive escalating doses of HMPL-A580 to evaluate safety, tolerability, and determine the maximum tolerated dose (MTD)

Approximately 12 months

Dose Expansion/Dose Optimization (Phase IIa)

Participants receive HMPL-A580 at recommended dose(s) for expansion to further evaluate safety, tolerability, and preliminary efficacy

Approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

At least 8 weeks post dose of first participant up to approximately 24 months

What Are the Treatments Tested in This Trial?

Interventions

• HMPL-A580

How Is the Trial Designed?

Group I: Part B(Phase IIa) Dose Expansion/Dose Optimization Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Hutchmed

Lead Sponsor

Trials

38

Recruited

6,700+

Citations

1.

aacrjournals.org

aacrjournals.org/cancerres/article/86/7_Supplement/4549/779492/Abstract-4549-Discovery-of-HMPL-A580-a-first-in

Discovery of HMPL-A580, a first-in-class antibody-targeted ...

In a 38-human solid tumor cell line panel, HMPL-A580 potently inhibited EGFR-expression tumor cell proliferation. The tumor cells harboring EGFR ...

2.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/hutchmed-begins-hmpl-a580-trial/

HUTCHMED begins Phase I/IIa trial of HMPL-A580 for ...

The first-in-human, multi-centre, open-label trial is designed to assess the tolerability, safety, immunogenicity, preliminary efficacy and ...

3.

hutch-med.com

hutch-med.com/a580-global-phase-i/

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ...

HMPL-A580 is a first-in-class ATTC comprising a highly selective and potent PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via a ...

4.

quiverquant.com

quiverquant.com/news/HUTCHMED+to+Present+New+Data+on+HMPL-A580+and+Surufatinib+at+AACR+Annual+Meeting+2026

HUTCHMED to Present New Data on HMPL-A580 and ...

Strong anti-tumor effects demonstrated by HMPL-A580 in various cancer models reinforce HUTCHMED's potential to address significant unmet medical ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07396584

Study Details | NCT07396584 | HMPL-A580 in Participants ...

To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 ...

6.

biospace.com

biospace.com/press-releases/hutchmed-highlights-data-to-be-presented-at-aacr-annual-meeting-2026

HUTCHMED Highlights Data to be Presented at AACR ...

In a 38-human solid tumor cell line panel, HMPL-A580 potently inhibited EGFR-expression tumor cell proliferation. The tumor cells harboring EGFR ...

7.

markets.ft.com

markets.ft.com/data/announce/detail?dockey=1330-9686051en-66ON6RLE1OSR1ODCPF5J51MC93

Company Announcement - FT.com - Markets data

In a 38-human solid tumor cell line panel, HMPL-A580 potently inhibited EGFR-expression tumor cell proliferation. The tumor cells harboring EGFR ...