Solid Tumor, AdultPhase 1/2NCT07718581
HMPL-A830 in Solid Tumors
A Phase 1/2 study testing HMPL-A830 in people with Solid Tumor, Adult, run by Hutchmed at 14 sites in 2 countries.
Trial summary
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HMPL-A830
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 24 Sep 2026to 15 Dec 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
- 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
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A830
- 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
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, +86 13911219511, doctorshenlin@sina.cn
- Not yet recruiting
Jilin Cancer Hospital
Changchun
Haifeng Liu, 0431-80596336, Liuhaifeng529@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha
Yongchang Zhang
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu
Li Zheng
- Recruiting
The Sixth Affiliated Hospital,Sun Yat-sen University
Guangzhou
Yanhong Deng, 13925106525, 13925106525@163.com
- Recruiting
Shandong Cancer Hospital
Jinan
shuqin Ni, +86 15553115936, nsq163@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing
Xiaofeng Chen, +86 13585172066, Xiaofengch198019@126.com
- Not yet recruiting
Shanxi Provincial Cancer Hospitial
Taiyuan
Hongxia Lu
United States6 sites, 6 recruiting
- Not yet recruiting
BRCR Global
Coral Springs, Florida, 33065
Sumit Sawhney, 561-447-0614, Ssawhney.md@brcrglobal.com
- Not yet recruiting
START New Jersey
East Brunswick, New Jersey, 08816
Bruno Fang, 732-390-7725, Bruno.fang@startresearch.com
- Not yet recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa Johnson, 615-329-7640, mjohnson@tnonc.com
- Not yet recruiting
University of California Irvine Medical Center
Orange, California, 92868
Zhaohui Arter, 714-456-7890, zarter@hs.uci.edu
- Not yet recruiting
Florida Clinical Trials Group
Plantation, Florida, 33322
Chintan Gandhi, 772-297-3057, cgandhi@floridactg.com
- Not yet recruiting
START Mountain Region
West Valley City, Utah, 84119
Jose Pacheco, 801-907-4750, jose.pacheco@startresearch.com
About this study
Official title: A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
Read the detailed description
Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.
Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors
- Conditions
- Solid Tumor, Adult
- Being tested
- HMPL-A830
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-A830Drug
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6
predefined dose levels
HMPL-A830Drug
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
| Study group | Role | What they receive |
|---|---|---|
| Part A (Dose Escalation) | Experimental | Not described Receives: Drug: HMPL-A830 |
| Part B (Dose Optimization) | Experimental | Not described Receives: Drug: HMPL-A830 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Number of Participants With of DLTs
Measured: Approximately 12 months
Overview of Treatment-emergent Adverse Events (TEAEs)
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Measured: Approximately 12 months
Objective Response Rate (ORR)
Assessed by investigators according to RECIST 1.1
Measured: Approximately 24 months
Recommended doses for phase II or III studies (RP2D or RP3D)
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.
Measured: Approximately 12 months
Secondary outcomes (8)
Disease control rate (DCR)
The DCR by RECIST 1.1
Measured: Approximately 2 years
Progression-free survival (PFS)
The time from the first dose of study drug to the date of first radiographic PD per RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Approximately 2 years
Pharmacokinetic Analysis(Cmax)
Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Measured: Approximately 2 years
Pharmacokinetic Analysis (Cmin)
Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Measured: Approximately 2 years
Pharmacokinetic Analysis(Tmax)
Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Measured: Approximately 2 years
Pharmacokinetic Analysis((AUClast)
Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Measured: Approximately 2 years
Pharmacokinetic Analysis((AUCtau)
Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Measured: Approximately 2 years
Incidence of anti-drug antibodies (ADAs) against HMPL-A830
Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.
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 posted22 Jul 2026
- Study start24 Sep 2026
- Primary completion23 May 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, 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
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718581
- Sponsor's protocol ID
- 2026-830-GLOB1
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 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-A830 in Solid Tumors
- ClinicalTrials.gov ID
- NCT07718581
- Acronym / sponsor ID
- 2026-830-GLOB1
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 23 May 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 22 Jul 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 (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
Detailed description
Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.
Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (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 (Dose Escalation) | Experimental | Drug: HMPL-A830 |
| Part B (Dose Optimization) | Experimental | Drug: HMPL-A830 |
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 (6 listed)
- 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
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A830
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-A830Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels | Drug | Part A (Dose Escalation) |
| HMPL-A830Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types. | Drug | Part B (Dose Optimization) |
Primary outcome
DLTs
Time frame: Approximately 12 months
Number of Participants With of DLTs
Overview of Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 12 months
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Objective Response Rate (ORR)
Time frame: Approximately 24 months
Assessed by investigators according to RECIST 1.1
Recommended doses for phase II or III studies (RP2D or RP3D)
Time frame: Approximately 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.
8 secondary outcomes
Disease control rate (DCR)
Time frame: Approximately 2 years
Progression-free survival (PFS)
Time frame: Approximately 2 years
Pharmacokinetic Analysis(Cmax)
Time frame: Approximately 2 years
Pharmacokinetic Analysis (Cmin)
Time frame: Approximately 2 years
Pharmacokinetic Analysis(Tmax)
Time frame: Approximately 2 years
Pharmacokinetic Analysis((AUClast)
Time frame: Approximately 2 years
Pharmacokinetic Analysis((AUCtau)
Time frame: Approximately 2 years
Incidence of anti-drug antibodies (ADAs) against HMPL-A830
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 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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-A830 in people with Solid Tumor, 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 6 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 1 Oct 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?
DLTs (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 1 Oct 2026.