Solid TumorsPhase 1NCT07624864

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

A Phase 1 study testing Hemay5087 in people with Solid Tumors, run by Ganzhou Hemay Pharmaceutical Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumors
What is being tested?: Hemay5087
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 15 Jul 2026to 30 Jun 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

jingyi xu contact

86-022-24899621

xujingyi@hemay.com.cn

About this study

Official title: 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.

Conditions: Solid Tumors
Being tested: Hemay5087

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hemay5087Drug
intravenous infusion，once every 3 weeks

Study groups in NCT07624864
Study group	Role	What they receive
Experimental group	Experimental	Intravenous infusion, Once per treatment cycle Receives: Drug: Hemay5087

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

Objective Response Rate
Measured: 3 weeks of treatment
Duration of Response
Measured: 3 weeks of treatment
Disease Control Rate
Measured: 3 weeks of treatment
Time to Response
Measured: 3 weeks of treatment
Progression-Free Survival
Measured: 3 weeks of treatment
Maximum Plasma Concentration （Cmax）
Pharmacokinetic (PK) profile
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202630 Jun 2028

First posted3 Jun 2026
Study start15 Jul 2026 (estimated)
Primary completion30 Apr 2028 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07624864
Sponsor's protocol ID: HM5087ST1S01
Status last verified: May 2026
First submitted: 22 May 2026
Last updated: 3 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

jingyi xu

86-022-24899621

xujingyi@hemay.com.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
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RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07624864
Acronym / sponsor ID: HM5087ST1S01
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 15 Jul 2026 (estimated)
Primary completion: 30 Apr 2028 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 3 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental group	Experimental	Drug: Hemay5087Intravenous infusion, Once per treatment cycle

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hemay5087intravenous infusion，once every 3 weeks	Drug	Experimental group

Primary outcome

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

16 secondary outcomes

Objective Response Rate
Time frame: 3 weeks of treatment
Duration of Response
Time frame: 3 weeks of treatment
Disease Control Rate
Time frame: 3 weeks of treatment
Time to Response
Time frame: 3 weeks of treatment
Progression-Free Survival
Time frame: 3 weeks of treatment
Maximum Plasma Concentration （Cmax）
Time frame: 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）
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.

Related trials for Solid Tumors

Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

jingyi xu contact

86-022-24899621

xujingyi@hemay.com.cn

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hemay5087 in people with Solid Tumors, run by Ganzhou Hemay Pharmaceutical Co., Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jingyi xu (86-022-24899621, xujingyi@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 3 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07624864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.