Advanced Solid TumorsPhase 1NCT07004296
A Study of HDM2005 in Patients With Advanced Solid Tumor
A Phase 1 study testing HDM2005 in people with Advanced Solid Tumors, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HDM2005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2025to 1 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent.
- Male or female aged ≥ 18 years at the time of signing the ICF;
- ECOG performance status of 0-1.
- Life expectancy of at least 3 months.
- Specific types of advanced solid tumors that have been confirmed by histopathological examination.
- Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type.
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- All subjects are required to provide archived tissue (5 unstained sections) obtained within the previous 2 years or fresh tissue for ROR1 expression testing at the central laboratory.
- Presence of radiographically measurable disease.
- Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy.
- Has adequate organ function.
- Female subjects of childbearing potential should agree to use contraception methods during the study and for 6 months after the end of the study; have a negative serum pregnancy test within 7 days before study enrollment; and male subjects should agree to use contraceptive avoidance measures during the study and for 6 months after the end of the study.
Who cannot join
- Patients with active brain metastases (defined as stable for < 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases).
- Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al.
- History of severe bleeding disorders .
- History of chronic pancreatitis or acute pancreatitis within 6 months.
- History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage,VEGF inhibitors, platinum and other drugs injection (subjects with stable symptoms for at least one week after treatment can be enrolled).
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- Prior solid organ transplantation.
- Has peripheral neuropathy of Grade >1.
- Has significant cardiovascular or cerebrovascular diseases.
- Has an uncontrolled ongoing infection.
- Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis.
- Receiving corticosteroids (prednisone equivalent more than10 mg/day).
- Contraindication to any component of HDM2005.
- History of drug anaphylactic shock, severe food allergy, uncontrolled asthma or COPD.
- Female subjects who are pregnant, lactating or planning to become pregnant during the study.
- Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements.
- Prior or current evidence of any disease, treatment, or laboratory abnormality that, in the opinion of the investigator, could affect the outcome of the study, prevent the subject from participating in the study entirely, or is not in the subjects' best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye
About this study
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HDM2005 in Patients With Advanced Solid Tumors
This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- HDM2005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2005Drug
HDM2005 will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| HDM2005 | Experimental | In dose escalation phase, participants will be administered escalating doses of HDM2005 at 1.8~2.5mg/kg IV on Day 1 of repeated 21-day cycles or 1.2~2.0mg/kg IV on Day 1 of repeated 14-day cycles .
In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 . Receives: Drug: HDM2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Measured: up to 21 days or 28 days following first dose
Incident and severity of adverse events(for dose escalation phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first.
Progression-free survival(PFS)(for dose expansion phase)
PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1.
Measured: Approximately 30 months
Objective Response Rate (ORR)(for dose expansion phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Measured: Approximately 18 months
Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data. The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic and efficacy data.
Measured: Approximately 30 months
Secondary outcomes (6)
Plasma concentration of HDM2005, total antibody and the free MMAE
Plasma concentration of HDM2005, total antibody and the free MMAE will be reported for each arm.
Measured: up to 28 days following last dose
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
Measured: up to 28 days following last dose
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Measured: Approximately 18 months
Time to Response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.
Measured: Approximately 30 months
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.
Measured: Approximately 30 months
Overall survival (OS)
OS is defined as the interval from the start of study therapy to death from any cause.
Measured: Approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start29 May 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004296
- Sponsor's protocol ID
- HDM2005-103
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jun 2025
- 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HDM2005 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07004296
- Acronym / sponsor ID
- HDM2005-103
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Jun 2025 (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 study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDM2005 | Experimental | Drug: HDM2005In dose escalation phase, participants will be administered escalating doses of HDM2005 at 1.8~2.5mg/kg IV on Day 1 of repeated 21-day cycles or 1.2~2.0mg/kg IV on Day 1 of repeated 14-day cycles . In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent.
- Male or female aged ≥ 18 years at the time of signing the ICF;
- ECOG performance status of 0-1.
- Life expectancy of at least 3 months.
- Specific types of advanced solid tumors that have been confirmed by histopathological examination.
Key exclusion criteria (17 listed)
- Patients with active brain metastases (defined as stable for < 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases).
- Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al.
- History of severe bleeding disorders .
- History of chronic pancreatitis or acute pancreatitis within 6 months.
- History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
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 |
|---|---|---|
| HDM2005HDM2005 will be administered via IV infusion. | Drug | HDM2005 |
Primary outcome
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
Time frame: up to 21 days or 28 days following first dose
DLT will be determined by definition during the DLT observation period.
Incident and severity of adverse events(for dose escalation phase)
Time frame: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first.
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Progression-free survival(PFS)(for dose expansion phase)
Time frame: Approximately 30 months
PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1.
Objective Response Rate (ORR)(for dose expansion phase)
Time frame: Approximately 18 months
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
Time frame: Approximately 30 months
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data. The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic and efficacy data.
6 secondary outcomes
Plasma concentration of HDM2005, total antibody and the free MMAE
Time frame: up to 28 days following last dose
Immunogenicity
Time frame: up to 28 days following last dose
Objective Response Rate (ORR)(for dose escalation phase)
Time frame: Approximately 18 months
Time to Response (TTR)
Time frame: Approximately 30 months
Duration of Response (DOR)
Time frame: Approximately 30 months
Overall survival (OS)
Time frame: Approximately 30 months
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 8 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDM2005 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 11 inclusion and 17 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 8 Jun 2025. 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 Jun Zhou (18061872796, hdgdzhoujun@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase) (time frame: up to 21 days or 28 days following first dose). The study lists 5 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 8 Jun 2025.