A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181

NCT07446816 | Recruiting Phase 1

• 1 other identifier: HM181ST1S02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Efficacy indicators

  Objective response rate (ORR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (1)

• Safety indicators

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Intravenous infusion, Once per treatment cycle

Drug: Hemay181

Interventions

Hemay181 DRUG

intravenous infusion，once every 3 weeks

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily signed a written informed consent form before the start of the study;
• 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 .
• 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;
• 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) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\].
• Subjects with ECOG PS score of 0-1;
• Subjects with expected survival more than 3 months;
• 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;

You may not qualify if:

• Women during pregnancy or breastfeeding;
• 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;
• Having received drug treatment from another clinical trial within the four weeks prior to enrolment;
• Aallergy to the active ingredient or excipients of the investigational medicinal product;
• Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
• The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (1)

Xinxiang Medical University First Affiliated Hospital

Xinxiang, Henan, 45310, China

RECRUITING

Central Study Contacts

Xu, Doctor

CONTACT

86-022-24899621; xujingyi@hemay.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: March 3, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-12

Locations

CN (1)