Patients With Advanced Stage Solid TumorsPhase 1NCT03982303
Phase I Study of Hemay102 in Patients With Advanced Solid Tumors
A Phase 1 study testing Hemay102 in people with Patients With Advanced Stage Solid Tumors, run by Tianjin Hemay Oncology Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Advanced Stage Solid Tumors
- What is being tested?
- Hemay102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2019to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤70 years old, male or female;
- A patient who has been confirmed by histology or cytology to have advanced or metastatic solid tumors (in the patients with locally advanced hepatocellular carcinoma or metastatic liver cancer, patients can be recruited by clinical diagnosis) and who have failed standard treatment or who are unable to receive/do not have effective treatment;
- At least one evaluable tumor lesion (spiral CT scan with a long diameter ≥ 10 mm, in accordance with RECIST version 1.1);
- ECOG PS score 0~1 within 1 week before enrollment;
- Estimated survival time of more than 3 months;
- Appropriate hematopoietic function: white blood cell count ≥ 3 × 10^9 / L; absolute neutrophil count ≥ 1.5 × 10^9 / L; platelet count ≥ 100 × 10^9 / L; hemoglobin ≥ 90 g / L;
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- Appropriate liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Proper renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL / min according to the Cockcroft-Gault formula;
- For clinically confirmed unresectable locally advanced hepatocellular carcinoma or metastatic liver cancer, the patient's liver function must meet the criteria below: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, Child-Pugh score A or B Grade (≤7 points), blood ammonia ≤100μmol/L (only for patients with hepatocellular carcinoma);
- A qualified male or female patient with fertility must agree to use a reliable method of contraception (hormone or barrier method) after signing the informed consent until at least 12 weeks after the last dose;
- Subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form;
- Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the trial regulations.
Who cannot join
- Subjects known to have or suspected to have brain metastases;
- Have received radiation therapy within 4 weeks before enrollment;
- Drugs that may affect the metabolism of this product, such as CYP3A4 strong inducer (rifampicin, carbamazepine, phenytoin, etc.) or strong inhibitors (clarithromycin, protease, triazole antifungals, etc.), should be combined within 2 weeks before the study or during the study period;
- Patients who have previously received anthracycline treatment; or who are known to have a history of allergies to anthracyclines (eg, doxorubicin, epirubicin);
- Have active infection or HIV-positive infection or other serious illness;
- Untreated active hepatitis C (anti-HCV antibody positive and HCV RNA positive patients cannot be enrolled); untreated active hepatitis B (HBsAg positive and HBV DNA ≥ 2000 IU/mL) (Note: Hepatitis B subjects treated with treatment also met the inclusion criteria if the following criteria were met: HBV viral load was less than 2000 IU/mL before the first dose of study drug, or patients who are on HBV treatment, and patients with viral load lower than 2000 IU/mL can also be enrolled);
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- Uncontrolled or important cardiovascular disease, which included a) New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment (including atrial fibrillation, at screening) within 6 months prior to the first study drug administration Supraventricular tachycardia, ventricular tachycardia or ventricular fibrillation, or left ventricular ejection fraction (LVEF) < 50%; b) Primary cardiomyopathy (eg dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undetermined cardiomyopathy); c) Clinically significant QTc interval prolongation history, or screening period QTc interval (corrected by Bazette) ≥ 450ms (male) or ≥ 470ms (female); d) Coronary heart disease with symptoms requiring medication; e) Uncontrollable hypertension (refers to post-treatment systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg);
- A history of hemorrhagic or thromboembolic events in the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, and spontaneous bleeding of the tumor;
- Medical treatment for other clinical trials within 4 weeks prior to enrollment;
- <4 weeks after major surgery or trauma after enrollment;
- Must take other treatments during the trial, such as other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or Chinese medicine;
- Concomitant mental illness;
- The investigator believes that the subject is not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university cancer hoapital
Tianjin
Ti Zhang, Ph.D., 86-22-23340123 ext. 3094, zhangti@tjmuch.com
About this study
Official title: A Dose Escalation Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Hemay102 in Patients With Advanced Solid Tumors
This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.
Read the detailed description
Dose escalation:
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
- Being tested
- Hemay102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay102Drug
Hemay102 was administered through i.v. infusion for 4hrs.
| Study group | Role | What they receive |
|---|---|---|
| Hemay102 at the dosage of 5mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 5mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 10mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 10mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 20mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 20mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 40mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 40mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 60mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 60mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 90mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 90mg/m2. Receives: Drug: Hemay102 |
| Hemay102 at the dosage of 120mg/m2 | Experimental | Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 120mg/m2. Receives: Drug: Hemay102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Number of participants with adverse events
Measured: from baseline until 4 weeks after the study day
Secondary outcomes (4)
Objective response rate
Objective response rate (complete response rate + partial response rate) according to RECIST v1.1
Measured: At screening, every 6 weeks of treatment up to 18 months
Clinical benefit rate
Clinical benefit rate defined as percentage of patients with stable disease (SD) ≥ 6 months/partial response (PR)/complete response (CR). according to RECIST v1.1
Measured: At screening, every 6 weeks of treatment up to 18 months
Progression Free Survival
Progression Free Survival defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria)
Measured: 18 months after treatment initiation
AUC
Area under the plasma concentration versus time curve of Hemay102
Measured: 0, 1, 2, 3, 5, 8, 12, 24, 48 and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start3 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Stage 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Oncology Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ti Zhang, Ph.D., Principal investigator, Tianjing medical university cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982303
- Sponsor's protocol ID
- HM102ST1S01
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Hemay102 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03982303
- Acronym / sponsor ID
- HM102ST1S01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Tianjin Hemay Oncology Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jun 2019 (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.
This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.
Detailed description
Dose escalation:
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Hemay102 at the dosage of 5mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 5mg/m2. |
| Hemay102 at the dosage of 10mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 10mg/m2. |
| Hemay102 at the dosage of 20mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 20mg/m2. |
| Hemay102 at the dosage of 40mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 40mg/m2. |
| Hemay102 at the dosage of 60mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 60mg/m2. |
| Hemay102 at the dosage of 90mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 90mg/m2. |
| Hemay102 at the dosage of 120mg/m2 | Experimental | Drug: Hemay102Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 120mg/m2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and ≤70 years old, male or female;
- A patient who has been confirmed by histology or cytology to have advanced or metastatic solid tumors (in the patients with locally advanced hepatocellular carcinoma or metastatic liver cancer, patients can be recruited by clinical diagnosis) and who have failed standard treatment or who are unable to receive/do not have effective treatment;
- At least one evaluable tumor lesion (spiral CT scan with a long diameter ≥ 10 mm, in accordance with RECIST version 1.1);
- ECOG PS score 0~1 within 1 week before enrollment;
- Estimated survival time of more than 3 months;
Key exclusion criteria (13 listed)
- Subjects known to have or suspected to have brain metastases;
- Have received radiation therapy within 4 weeks before enrollment;
- Drugs that may affect the metabolism of this product, such as CYP3A4 strong inducer (rifampicin, carbamazepine, phenytoin, etc.) or strong inhibitors (clarithromycin, protease, triazole antifungals, etc.), should be combined within 2 weeks before the study or during the study period;
- Patients who have previously received anthracycline treatment; or who are known to have a history of allergies to anthracyclines (eg, doxorubicin, epirubicin);
- Have active infection or HIV-positive infection or other serious 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 |
|---|---|---|
| Hemay102Hemay102 was administered through i.v. infusion for 4hrs. | Drug | Hemay102 at the dosage of 10mg/m2, Hemay102 at the dosage of 120mg/m2, Hemay102 at the dosage of 20mg/m2, Hemay102 at the dosage of 40mg/m2, Hemay102 at the dosage of 5mg/m2, Hemay102 at the dosage of 60mg/m2, Hemay102 at the dosage of 90mg/m2 |
Primary outcome
Number of participants with adverse events
Time frame: from baseline until 4 weeks after the study day
Number of participants with adverse events
4 secondary outcomes
Objective response rate
Time frame: At screening, every 6 weeks of treatment up to 18 months
Clinical benefit rate
Time frame: At screening, every 6 weeks of treatment up to 18 months
Progression Free Survival
Time frame: 18 months after treatment initiation
AUC
Time frame: 0, 1, 2, 3, 5, 8, 12, 24, 48 and 72 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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. This study is not recruiting at the moment.
Ti Zhang, Ph.D. principal investigator
Tianjing medical university cancer hospital
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 Hemay102 in people with Patients With Advanced Stage Solid Tumors, run by Tianjin Hemay Oncology 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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueying Zhen, Ph.D. (86-22-2492-9366, zhenyueying@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: from baseline until 4 weeks after the study day). 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 1 Oct 2021.