NCT07446816 A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181
| NCT ID | NCT07446816 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ganzhou Hemay Pharmaceutical Co., Ltd |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2026-08 |
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 24 participants in total. It began in 2025-12-03 with a primary completion date of 2026-08.
⚠ 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
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who voluntarily signed a written informed consent form before the start of the study; 2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy . 3. Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1; 4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\]. 5. Subjects with ECOG PS score of 0-1; 6. Subjects with expected survival more than 3 months; 7. Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study; Exclusion Criteria: 1. Women during pregnancy or breastfeeding; 2. HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal; 3. Having received drug treatment from another clinical trial within the four weeks prior to enrolment; 4. Aallergy to the active ingredient or excipients of the investigational medicinal product; 5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness; 6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07446816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, 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 NCT07446816 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 NCT07446816 currently recruiting?
Yes, NCT07446816 is actively recruiting participants. Contact the research team at xujingyi@hemay.com.cn for enrollment information.
Where is the NCT07446816 trial being conducted?
This trial is being conducted at Xinxiang, China.
Who is sponsoring the NCT07446816 clinical trial?
NCT07446816 is sponsored by Ganzhou Hemay Pharmaceutical Co., Ltd. The trial plans to enroll 24 participants.