Hemay181 for advanced solid tumors
A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours
This trial will try the experimental drug Hemay181 in people with advanced solid tumors who have not responded to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ganzhou Hemay Pharmaceutical Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Xinxiang, Henan) |
| Trial ID | NCT07446816 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with pathologically confirmed advanced solid tumors, measurable disease per RECIST v1.1, ECOG 0–1, prior standard therapies exhausted or unavailable, and an expected survival over three months.
Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, without measurable lesions, or who still have effective standard treatment options are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Hemay181 could provide a new treatment option that shrinks tumors or slows disease in patients with advanced solid cancers who have no remaining standard therapies.
How similar studies have performed: Phase 1 trials of novel anti-cancer agents sometimes report early tumor responses, but there are no widely published clinical efficacy results for Hemay181 to date.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xinxiang, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.