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

NCT07624864 | Not Yet Recruiting Phase 1

• 1 other identifier: HM5087ST1S01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Intravenous infusion, Once per treatment cycle

Drug: Hemay5087

Interventions

Hemay5087 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 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) \[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\];
• Subjects with ECOG PS score of 0-1;
• Subjects with expected survival more than 3 months;
• 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;

You may not qualify if:

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

Central Study Contacts

jingyi xu

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: May 22, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05