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Advanced Solid TumorsPhase 1NCT07539285

A Study of HDM2024 in Participants With Advanced Solid Tumors

A Phase 1 study testing HDM2024 in people with Advanced Solid Tumors, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are: Is the drug safe and tolerable ? Does the drug exhibit antitumor activity ? Participants will receive the study drug once every three weeks, and imaging-based efficacy… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HDM2024
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteChina
Study dates
10 Apr 2026to 28 Dec 2028
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed.
  • 2. Male or female participants aged 18 to 75 years (inclusive).
  • 3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have experienced disease progression on or after standard therapy , or are intolerant to standard therapy, or for whom no effective standard of care is available.
  • 4. Participants who are able to provide fresh or archival tumor tissue during the screening period. Tumor tissue will be collected for biomarker testing at a central laboratory, including immunohistochemistry for EGFR and HER3 .
  • 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 .
  • 6. Life expectancy ≥3 months.
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  • 7. According to RECIST v1.1, the participant must have at least one measurable lesion .
  • 8. Participants with good organ function as demonstrated by screening laboratory test results.
  • 9. The fertile participants agreed to take effective contraceptive measures during the study and after its conclusion; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing.
  • 10. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • 1. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and/or HER3.
  • 2. Participants who have received the following treatments:
  • Participants who have undergone major surgery within 4 weeks before the first dose;
  • Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;
  • Participants who are receiving continuous systemic corticosteroid therapy ; low-dose corticosteroids are permitted if the dose of systemic corticosteroids has been stable for 4 weeks;
  • Participants who have received anti-tumor treatments within 4 weeks before the first dose, or are still within 5 half-lives of the last dose of the most recent anticancer therapy (whichever is longer). Traditional Chinese medicines with approved anticancer indications within 2 weeks prior to the first administration of study drug.
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  • 3. Participants with other malignant tumor within the past 5 years, other than the tumor treated in this study, with the exception of locally cured tumors .
  • 4. Participants with related AEs (except for alopecia and ≤ Grade 2 sensory neuropathy) caused by previous treatment that have not recovered to ≤ Grade 1 or baseline level.
  • 5. Participants with known weight loss of >10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.
  • 6. Participants with serious complications or medical histories involving important organs.
  • 7. Participants with known active central nervous system (CNS) metastasis.
  • 8. Participants with any of the cardiovascular/cerebrovascular disorders, symptoms, or manifestations.
  • 9. Participants with the following conditions will be excluded at screening: active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), with the exception of asymptomatic chronic hepatitis B or C virus carriers.
  • 10. Participants with a history of interstitial pneumonia or other moderate to severe lung disorders that seriously affect lung function.
  • 11. Participants with severe infection during the screening period.
  • 12. Participants with other diseases that may affect the efficacy and safety of the study drug.
  • 13. Participants with uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites during the screening period.
  • 14. Participants with unstable thrombotic events requiring therapeutic intervention within 6 months before screening; however, thrombosis related to infusion devices is not included.
  • 15. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study period.
  • 16. Participants who have received strong CYP3A4 inhibitors and inducers therapy within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors and inducers during the study intervention and within 30 days after the last dose .
  • 17. Participants with history of solid organ transplant.
  • 18. Participants with known or suspected history of severe allergy to any component of the study drug or its analogues.
  • 19. Pregnant and lactating women.
  • 20. Participants who are deemed unsuitable for this study (e.g., poor compliance, etc.) by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhou Caicun contact

+8613301825532

caicunzhoudr@163.com

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

    Zhou Caicun, +8613301825532, caicunzhoudr@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Efficacy of HDM2024 in Participants With Advanced Solid Tumors

The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:

  • Is the drug safe and tolerable ?
  • Does the drug exhibit antitumor activity ?

Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.

Read the detailed description

Target population are patients with advanced solid tumors .

Being tested
HDM2024
Keywords
ADC, advanced solid tumors, EGFR, HER3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDM2024Drug

    ADC drug targeting EGFR and HER3

Study groups in NCT07539285
Study groupRoleWhat they receive
HDM2024ExperimentalHDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) \& human epidermal growth factor receptor 3 (HER3) )
Receives: Drug: HDM2024

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal tolerance dose (MTD) of HDM2024

    The MTD is defined as the dose level at which the estimated toxicity probability is closest to the target toxicity rate during the Dose-limiting toxicity (DLT) observation period of the dose escalation stage.

    Measured: DLT will be evaluated on 21 days of observation period

  2. Determination of the Recommended Phase 2 dose (RP2D)

    Measured: Approximately 1 years

  3. Incidence and severity of Treatment-Emergent Adverse Events

    Incidence rates of adverse events (AE), serious adverse events (SAE)per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0.

    Measured: Approximately 1 years

Secondary outcomes (8)

  1. Time to peak (Tmax) of HDM2024

    Tmax of HDM2024, total antibody, and exatecan will be measured

    Measured: Approximately 1 years

  2. Half-life time (t1/2) of HDM2024

    t1/2 of HDM2024, total antibody, and exatecan will be measured

    Measured: Approximately 1year

  3. Peak Plasma Concentration (Cmax) of HDM2024

    Cmax of HDM2024, total antibody, and exatecan will be measured

    Measured: Approximately 1 year

  4. Area under the plasma concentration versus time curve (AUC) of HDM2024

    AUC of HDM2024, total antibody, and exatecan will be measured

    Measured: approximately 1 year

  5. Objective response rate (ORR)

    ORR assessed based on RECIST v1.1 criterion

    Measured: Approximately 1 year

  6. Disease control rate (DCR)

    DCR assessed based on RECIST v1.1 criterion

    Measured: Approximately 1 year

  7. Progression-free survival (PFS)

    PFS assessed based on RECIST v1.1 criterion

    Measured: Approximately 1year

  8. Overall survival (OS)

    OS of 6-months and 12-months

    Measured: Approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start10 Apr 2026 (estimated)
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion28 Dec 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07539285
Sponsor's protocol ID
HDM2024-101
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HDM2024 in people with Advanced Solid Tumors, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.

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 10 inclusion and 24 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 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.

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?

Contact Zhou Caicun (+8613301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal tolerance dose (MTD) of HDM2024 (time frame: DLT will be evaluated on 21 days of observation period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539285.

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 20 Apr 2026.

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