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

Official title

A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours

Overview

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.

Interventions

• Drug Hemay181
  intravenous infusion，once every 3 weeks

Primary outcome measures

• Efficacy indicators [Time frame: 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 outcome measures (1)

• Safety indicators [Time frame: 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]

Eligibility criteria

Inclusion criteria

• 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;

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Xinxiang Medical University First Affiliated Hospital — Xinxiang

Identifiers

NCT: NCT07446816 · HM181ST1S02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗