Solid Tumors, AdultPhase 1/2NCT07396584
HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
A Phase 1/2 study testing HMPL-A580 in people with Solid Tumors, Adult, run by Hutchmed at 14 sites in 2 countries.
Trial summary
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- HMPL-A580
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 4 Mar 2026to 30 Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Who cannot join
- An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- Participant has received a live within 3 months before study enrollment
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A580
- Pregnant (positive pregnancy test) or lactating;
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
China8 sites, 8 recruiting
- Not yet recruiting
Jilin Provincial Cancer Hospital
Changchun
Liang Zhang
- Not yet recruiting
Hunan Cancer Hospital
Changsha
Yongchang Zhang, 860731 89762769, zhangyongchang@csu.edu.cn
- Not yet recruiting
Shandong Cancer Hospital
Jinan
Yuping Sun
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Song Qu, 860771 5323347, 13607887386@163.com
- Recruiting
Shanghai East Hospital
Shanghai
Caichun Zhou, 86021-58822171, caicunzhoudr@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Kunyu Yang, 86027 83262755, Yangky71@aliyun.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Feng Ye, 860592 2137252, yefengdoctor@sina.com
- Recruiting
Henan Cancer Hospital
Zhengzhou
Suxia Luo, 860371 65587412, luosxrm@163.com
United States6 sites, 6 recruiting
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Olatunji Alese, 404-778-1900, olatunji.alese@emory.edu
- Not yet recruiting
University of California Irvine Medical Center
Orange, California, 92868
Zhaohui Liao Arter, 714-456-6244, zarter@hs.uci.edu
- Recruiting
BRCR Global
Plantation, Florida, 33324
Sumit Sawhney, 561-447-0614, ssawhney.md@brcrglobal.com
- Recruiting
Florida Clinical Trials Group LLC (Plantation)
Plantation, Florida, 33324
Harshad Amin, 772-297-3057, harshamin@floridactg.com
- Not yet recruiting
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Lei Deng, 206-606-7017, ldeng1@fredhutch.org
- Recruiting
Florida Clinical Trials Group LLC (Tamarac)
Tamarac, Florida, 33319
Chintan Gandhi, 772-297-3057, cgandhi@floridactg.com
About this study
Official title: A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
Read the detailed description
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.
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 dose (RP3D) in participants with selected solid tumors.
- Conditions
- Solid Tumors, Adult
- Being tested
- HMPL-A580
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-A580Drug
Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.
HMPL-A580Drug
Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| Part A(Phase I) Dose Escalation | Experimental | Not described Receives: Drug: HMPL-A580 |
| Part B(Phase IIa) Dose Expansion/Dose Optimization | Experimental | Not described Receives: Drug: HMPL-A580 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
Measured: Approximately 12 months
Overview of Treatment-emergent Adverse Events (TEAEs)
To characterize the safety of HMPL-A580 at RDE(s)
Measured: Approximately 12 months
Objective Response Rate (ORR)
To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)
Measured: At least 8 weeks post dose of first participant up to approximately 24 months
Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580
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 dose (RP3D) in participants with selected solid tumors.
Measured: Approximately 12 months
Secondary outcomes (2)
disease control rate (DCR)
To assess the preliminary efficacy of HMPL-A580 in solid tumors
Measured: Approximately 2 years
progression-free survival (PFS)
To assess the preliminary antitumor activity of HMPL-A580 in selected solid tumors
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start4 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396584
- Sponsor's protocol ID
- 2025-580-GLOB1
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07396584
- Acronym / sponsor ID
- 2025-580-GLOB1
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
Detailed description
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.
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 dose (RP3D) in participants with selected solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A(Phase I) Dose Escalation | Experimental | Drug: HMPL-A580 |
| Part B(Phase IIa) Dose Expansion/Dose Optimization | Experimental | Drug: HMPL-A580 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
Key exclusion criteria (8 listed)
- An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- Participant has received a live within 3 months before study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-A580Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels. | Drug | Part A(Phase I) Dose Escalation |
| HMPL-A580Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors. | Drug | Part B(Phase IIa) Dose Expansion/Dose Optimization |
Primary outcome
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
Time frame: Approximately 12 months
To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
Overview of Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 12 months
To characterize the safety of HMPL-A580 at RDE(s)
Objective Response Rate (ORR)
Time frame: At least 8 weeks post dose of first participant up to approximately 24 months
To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)
Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580
Time frame: Approximately 12 months
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 dose (RP3D) in participants with selected solid tumors.
2 secondary outcomes
disease control rate (DCR)
Time frame: Approximately 2 years
progression-free survival (PFS)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florida Clinical Trials Group LLC (Plantation)
Plantation, United States
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HMPL-A580 in people with Solid Tumors, Adult, run by Hutchmed at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) (time frame: Approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.