Hemay181 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 1 study testing the safety and preliminary anti-tumor effects of Hemay181 in adults with advanced solid tumors who have exhausted effective standard therapies. Eligible participants must have at least one measurable lesion per RECIST v1.1, an ECOG performance status of 0–1, and an expected survival of more than three months. A required washout of prior therapies (at least 4 weeks or 5 half-lives) and recovery from treatment-related toxicities to ≤ Grade 1 is enforced before enrollment. The study is sponsored by Ganzhou Hemay Pharmaceutical Co., Ltd and is conducted at Xinxiang Medical University First Affiliated Hospital in Xinxiang, Henan, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xinxiang Medical University First Affiliated Hospital
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: Xu, Doctor
• Email: xujingyi@hemay.com.cn
• Phone: 86-022-24899621

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.