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
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.
- 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