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Solid TumorPhase 1NCT05749432

A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors

A Phase 1 study testing Hemay181 in people with Solid Tumor, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Solid Tumor
What is being tested?
Hemay181
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
20 Mar 2023to 31 Jul 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 to 65 years;
  • Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
  • Advanced solid tumors patients that confirmed by pathology (histology or cytology) with adequate standard therapy failure or currently have no effective standard treatment (such as breast, liver, lung, gastric cancer, colorectal cancer, etc.); Standard therapy failure is defined as: patients who have undergone at least 2 lines of standard antineoplastic therapy after recurrence/metastasis (including treatment-naïve stage IV) (if only 1-line therapy is recommended for the tumor, standard 1-line therapy shall prevail), and who have been confirmed by the investigator or have a clear disease progression or are intolerable by the medical history;
  • At least one lesion that can be evaluated by CT/MRI (measurable lesions are required) and meet the reproducible evaluation requirements in RECIST V1.1;
  • At least 4 weeks after the latest treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), at least 2 weeks after endocrine therapy, and have recovered from the toxic effects caused by previous treatment to lower than grade 1 (CTCAE version 5.0) [patients with hair loss (any grade), pigmentation (any grade), peripheral sensory neuropathy (grade ≤2) can be enrolled];
  • Eastern Cooperative Oncology Group(ECOG) score of 0,1;
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  • Life expectancy of at least three months;
  • Adequate bone marrow, liver, kidney function, meeting the following criteria:
  • ANC≥1.5×10^9/L, HB≥90g/L, PLT≥75×10^9/L; ALT≤2.5×ULN, AST≤2.5×ULN with no liver metastasis, or ALT≤5×ULN, AST≤5×ULN with liver metastasis; TBIL≤1.5×ULN; Serum creatinine ≤1.5×ULN;
  • All female and male subjects must agree and commit to the use of a reliable contraceptive regimen for the duration of the study and for at least 12 weeks after at the last dose of test article.

Who cannot join

  • Pregnant or lactating women;
  • Patients with known central nervous system metastatic disease;
  • Positive blood for human immunodeficiency virus (HIV antibody); Positive hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (HBV-DNA)>upper limit of normal; Active hepatitis C virus (HCV) infection;
  • Patients with active infection requiring intravenous anti-infective therapy;
  • Patients with a history of irinotecan allergic reactions or previous irinotecan gastrointestinal toxicity ≥ grade 3;
  • Have received drug therapy from other clinical trials within 4 weeks prior to enrollment;
  • Known allergy to the active ingredient or excipients of the test drug;
  • The investigator believes that the subject has any clinical or laboratory abnormalities and is not suitable to participate in this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Huiping Li, 13811012595, huipingli2012@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Antitumor Efficacy of Hemay181 in Patients With Advanced Solid Tumors

The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors.

Read the detailed description

The primary purpose of this study is to evaluate the safety and tolerability of Hemay181 in patients with advanced solid tumors, and to explore the maximum tolerated dose. The secondary purpose is to evaluate the pharmacokinetic profile of Hemay181 in patients with advanced solid tumors and to evaluate the preliminary evaluation of the anti-tumor efficacy of Hemay181.

The study will be conducted in two parts. Part one, trial will be conducted in about 24 subjects to determine safety and tolerability of Hemay181 in patients with advanced solid tumors. Part two, approximately 15-27 additional subjects with advanced solid tumors are included to better define the tolerability and preliminary efficacy of Hemay181.

Conditions
Solid Tumor
Being tested
Hemay181

What participants receive

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

  • Hemay181Drug

    Hemay181 will be given intravenously on the first day per cycle, and the treatment cycle is 21-days.

Study groups in NCT05749432
Study groupRoleWhat they receive
Hemay181ExperimentalPart one: Dose Escalation Group Hemay181 will be injected in doses of 4.5 mg/m^2, 9.0 mg/m^2, and 18 mg/m^2 until any drug-related toxicity of grade 2 or higher is observed in any dose group. Next, Hemay181 will be injected in doses of 36mg/m^2, 60mg/m^2, 90mg/m^2, 120mg/m^2, 150mg/m^2, 180mg/m^2, 210mg/m^2 until there are two cases of dose-limiting toxicity in a dose group. Part two: Extension Group Hemay181 will be injected in the highest three dose groups that had been assessed until disease progression.
Receives: Drug: Hemay181

What is being measured

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

  1. Number of participants with adverse events

    Measured: 3 weeks of treatment

  2. Incidence of dose-limiting toxicity (DLT) in each dose group

    Measured: 3 weeks of treatment

  3. Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181

    Measured: 3 weeks of treatment

  4. Subsequent recommended doses of Hemay181

    Measured: 3 weeks of treatment

Secondary outcomes (16)
  1. Objective Response Rate

    Measured: 3 weeks of treatment

  2. Duration of Response

    Measured: 3 weeks of treatment

  3. Disease Control Rate

    Measured: 3 weeks of treatment

  4. Time to Response

    Measured: 3 weeks of treatment

  5. Progression-Free Survival

    Measured: 3 weeks of treatment

  6. Maximum Plasma Concentration (Cmax)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  7. Time to reach maximum concentration (Tmax)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  8. Elimination half life(t1/2)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  9. Plasma Clearance(CL)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  10. 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, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  11. Mean Residence Time from 0 to infinite time(MRT 0-∞)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  12. 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, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  13. 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, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  14. Percentage of the residual area (AUC%Extra)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  15. Volume of distribution(Vz)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22

  16. Elimination rate constant(λz)

    Pharmacokinetic (PK) profile

    Measured: 0,0.75, 1.5, 1.75, 2, 2.5, 3.5, 5.5, 9.5, 13.5, 25.5, 49.5, 73.5, 97.5, 121.5 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.

  1. First posted1 Mar 2023
  2. Study start20 Mar 2023
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749432
Sponsor's protocol ID
HM181ST1S01
Status last verified
Mar 2025
First submitted
15 Feb 2023
Last updated
18 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hemay181 in people with Solid Tumor, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.

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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Huiping Li (13811012595, huipingli2012@hotmail.com), 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?
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 18 Apr 2025.

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