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.
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;
Show all 10Show fewer
- 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
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Huiping Li, 13811012595, huipingli2012@hotmail.com
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 group | Role | What they receive |
|---|---|---|
| Hemay181 | Experimental | Part 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.
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, 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
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
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
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
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
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
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
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
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
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
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.
- First posted1 Mar 2023
- Study start20 Mar 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05749432
- Acronym / sponsor ID
- HM181ST1S01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Mar 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemay181 | Experimental | Drug: Hemay181Part 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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];
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Hemay181Hemay181 will be given intravenously on the first day per cycle, and the treatment cycle is 21-days. | Drug | Hemay181 |
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, 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
Time to reach maximum concentration (Tmax)
Time frame: 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
Elimination half life(t1/2)
Time frame: 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
Plasma Clearance(CL)
Time frame: 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
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, 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
Mean Residence Time from 0 to infinite time(MRT 0-∞)
Time frame: 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
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, 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
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, 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
Percentage of the residual area (AUC%Extra)
Time frame: 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
Volume of distribution(Vz)
Time frame: 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
Elimination rate constant(λz)
Time frame: 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
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 18 Apr 2025.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
1 site in 1 country: see every site and its status.
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.