A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors

A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Hemay5087

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: jingyi xu; Phone Number: 86-022-24899621; Email: xujingyi@hemay.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v6.0) [except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk];
5. Subjects with ECOG PS score of 0-1;
6. Subjects with expected survival more than 3 months;
7. Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;

Exclusion Criteria:

1. Women during pregnancy or breastfeeding;
2. Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;
3. Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Intravenous infusion, Once per treatment cycle	Drug: Hemay5087; intravenous infusion，once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	3 weeks of treatment
Incidence of dose-limiting toxicity (DLT) in each dose group	3 weeks of treatment
Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181	3 weeks of treatment
Subsequent recommended doses of Hemay181	3 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate		3 weeks of treatment
Duration of Response		3 weeks of treatment
Disease Control Rate		3 weeks of treatment
Time to Response		3 weeks of treatment
Progression-Free Survival		3 weeks of treatment
Maximum Plasma Concentration （Cmax）	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Time to reach maximum concentration （Tmax）	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Elimination half life(t1/2)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Plasma Clearance（CL)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Mean Residence Time from 0 to infinite time(MRT 0-∞)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Area under the plasma concentration-time curve from 0 extrapolated to infinite time(AUC 0-∞)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Percentage of the residual area (AUC%Extra)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Volume of distribution(Vz)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22
Elimination rate constant(λz)	Pharmacokinetic (PK) profile	0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22

Collaborators and Investigators

• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HM5087ST1S01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No