A Clinical Study Evaluating the Preliminary Anti-tumor Ef... | NCT07446816

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

NCT07446816

Sponsor

Ganzhou Hemay Pharmaceutical Co., Ltd

Status

Recruiting

Last Update Posted

Mar 3, 2026Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

Hemay181

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Dec 10, 2025

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Mar 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Mar 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Label	Type	Description	Intervention Names
Experimental group	Experimental	Intravenous infusion, Once per treatment cycle	Drug: Hemay181

Name	Type	Description	Arm Group Labels	Other Names
Hemay181	Drug	intravenous infusion，once every 3 weeks	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety indicators	Occurrence of adverse events (AEs) and serious adverse events (SAEs)	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided