NCT07004296 A Study of HDM2005 in Patients With Advanced Solid Tumor
| NCT ID | NCT07004296 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-05-29 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent. 2. Male or female aged ≥ 18 years at the time of signing the ICF; 3. ECOG performance status of 0-1. 4. Life expectancy of at least 3 months. 5. Specific types of advanced solid tumors that have been confirmed by histopathological examination. 6. Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type. 7. 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. 8. Presence of radiographically measurable disease. 9. Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy. 10. Has adequate organ function. 11. 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. Exclusion Criteria: 1. Patients with active brain metastases (defined as stable for \< 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases). 2. 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. 3. History of severe bleeding disorders . 4. History of chronic pancreatitis or acute pancreatitis within 6 months. 5. History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease. 6. 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). 7. Prior solid organ transplantation. 8. Has peripheral neuropathy of Grade \>1. 9. Has significant cardiovascular or cerebrovascular diseases. 10. Has an uncontrolled ongoing infection. 11. Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis. 12. Receiving corticosteroids (prednisone equivalent more than10 mg/day). 13. Contraindication to any component of HDM2005. 14. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma or COPD. 15. Female subjects who are pregnant, lactating or planning to become pregnant during the study. 16. Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements. 17. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07004296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07004296 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07004296 currently recruiting?
Yes, NCT07004296 is actively recruiting participants. Contact the research team at hdgdzhoujun@eastchinapharm.com for enrollment information.
Where is the NCT07004296 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07004296 clinical trial?
NCT07004296 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 72 participants.