NSCLCPhase 1NCT04413227
A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors
A Phase 1 study testing Pegylated Recombinant Human Endostatin（PEG-ENDO） in people with NSCLC and Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Solid Tumor
- What is being tested?
- Pegylated Recombinant Human Endostatin（PEG-ENDO）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 2 Apr 2020to 30 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent.
- 18-70years old, male or female.
- Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy.
- At least one measurable disease according to RECIST v1.1.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Demonstrate adequate organ function -
Who cannot join
- uncontrolled primary CNS tumors, brain metastases, or meningeal metastases.
- Evidence of a tumor that compresses or invades major blood vessels.
- History of hemoptysis (>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months.
- Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO.
- Prior treatment with anti-agiogenetic agent.
- Pregnant female patients; breastfeeding female patients.
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Li Lin, Ph.D, 010-85136714, lilin_51@163.com
- Recruiting
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, 300060
Huang Dingzhi, Ph.D, 02223340123 ext. 3220, dingzhih72@163.com
About this study
Official title: A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
Read the detailed description
This is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts planning as following:
cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO 2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3 weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1
- Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel. Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after the first administration of PEG-ENDO. During the observation period of DLT (cycle 1), subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher ,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression (PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。
- Conditions
- NSCLC, Solid Tumor
- Being tested
- Pegylated Recombinant Human Endostatin（PEG-ENDO）
- Keywords
- pegylated recombinant human endostatin (PEG-ENDO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Recombinant Human Endostatin（PEG-ENDO）Drug
Also called Docetaxel
PEG-ENDO 1 mg/kg or 2 mg/kg or 4 mg/kg or 6 mg/kg or 8 mg/kg+Docetaxel 75 mg/m2，once every 3 weeks at day 1
| Study group | Role | What they receive |
|---|---|---|
| PEG-ENDO+Docetaxel | Experimental | PEG-ENDO( 1 mg/kg or 2mg/kg or 4mg/kg or 6mg/kg or 8mg/kg）+Docetaxel 75 mg/m2，once every 3 weeks at day 1 Receives: Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Incidence of Dose Limiting Toxicity
Measured: First 21days for dosing（Cycle1，each cycle is 21 days)
Adverse Event(AE)
Incidence of Adverse Events
Measured: From the time the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Serious Adverse Event(SAE)
Incidence of Serious Adverse Events
Measured: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Laborarory test abnormality
Incidence of clinically significant laboratory abnormalities
Measured: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Vital signs abnormality
Incidence of vital signs abnormalities
Measured: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Electrocardiogram(ECG) abnormality
Incidence of clinically significant ECG abnormalities
Measured: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Serum concentration
Serum concentration of PEG-ENDO
Measured: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
The maximum (or peak) serum ,Cmax
Cmax of PEG-ENDO following dose concentration.
Measured: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
AUC
The area under the plot of serum concentration of drug (not logarithm of the concentration) against time after drug administration.
Measured: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
other PK parameters
The other PK parameters (if applicable).
Measured: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
Maximum Tolerated Dose(MTD)
To determine the Maximum Tolerated Dose (MTD) of PEG-ENDO in subjects with Advanced / Metastatic NSCLC or Other Solid Tumors
Measured: First 21days for dosing（Cycle1，each cycle is 21 days)
Secondary outcomes (3)
Overall Response Rate(ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: at least 12 weeks
Duration of Response(DOR)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Measured: Estimated at 4 months after fist documented PD or CR
Progression-free survival (PFS)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by by Investigator assessment in accordance to RECIST 1.1
Measured: Estimated at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start2 Apr 2020
- Primary completion31 May 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang Dingzhi, Ph.D, Principal investigator, Tianjin Medical University Cancer Institute and HospitalLi Lin, Ph.D, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413227
- Sponsor's protocol ID
- SIM181202-PEGENDO-102
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
- ClinicalTrials.gov ID
- NCT04413227
- Acronym / sponsor ID
- SIM181202-PEGENDO-102
- Conditions
- NSCLC, Solid Tumor
- Keywords
- pegylated recombinant human endostatin (PEG-ENDO)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 2 Jun 2020 (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 primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
Detailed description
This is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts planning as following:
cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO 2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3 weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1
- Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel. Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after the first administration of PEG-ENDO. During the observation period of DLT (cycle 1), subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher ,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression (PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-ENDO+Docetaxel | Experimental | Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO）PEG-ENDO( 1 mg/kg or 2mg/kg or 4mg/kg or 6mg/kg or 8mg/kg）+Docetaxel 75 mg/m2，once every 3 weeks at day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent.
- 18-70years old, male or female.
- Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy.
- At least one measurable disease according to RECIST v1.1.
- Life expectancy of at least 3 months.
Key exclusion criteria (7 listed)
- uncontrolled primary CNS tumors, brain metastases, or meningeal metastases.
- Evidence of a tumor that compresses or invades major blood vessels.
- History of hemoptysis (>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months.
- Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO.
- Prior treatment with anti-agiogenetic agent.
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 |
|---|---|---|
| Pegylated Recombinant Human Endostatin（PEG-ENDO）Also: DocetaxelPEG-ENDO 1 mg/kg or 2 mg/kg or 4 mg/kg or 6 mg/kg or 8 mg/kg+Docetaxel 75 mg/m2，once every 3 weeks at day 1 | Drug | PEG-ENDO+Docetaxel |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: First 21days for dosing（Cycle1，each cycle is 21 days)
Incidence of Dose Limiting Toxicity
Adverse Event(AE)
Time frame: From the time the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Incidence of Adverse Events
Serious Adverse Event(SAE)
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Incidence of Serious Adverse Events
Laborarory test abnormality
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Incidence of clinically significant laboratory abnormalities
Vital signs abnormality
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Incidence of vital signs abnormalities
Electrocardiogram(ECG) abnormality
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Incidence of clinically significant ECG abnormalities
Serum concentration
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
Serum concentration of PEG-ENDO
The maximum (or peak) serum ,Cmax
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
Cmax of PEG-ENDO following dose concentration.
AUC
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
The area under the plot of serum concentration of drug (not logarithm of the concentration) against time after drug administration.
other PK parameters
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
The other PK parameters (if applicable).
Maximum Tolerated Dose(MTD)
Time frame: First 21days for dosing（Cycle1，each cycle is 21 days)
To determine the Maximum Tolerated Dose (MTD) of PEG-ENDO in subjects with Advanced / Metastatic NSCLC or Other Solid Tumors
3 secondary outcomes
Overall Response Rate(ORR)
Time frame: at least 12 weeks
Duration of Response(DOR)
Time frame: Estimated at 4 months after fist documented PD or CR
Progression-free survival (PFS)
Time frame: Estimated at 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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.
Huang Dingzhi, Ph.D principal investigator
Tianjin Medical University Cancer Institute and Hospital
Li Lin, Ph.D principal investigator
Beijing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegylated Recombinant Human Endostatin（PEG-ENDO） in people with NSCLC and Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 2 sites 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 7 inclusion and 7 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Huang Dingzhi, Ph.D (02223340123 ext. 3220, dingzhih72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: First 21days for dosing（Cycle1，each cycle is 21 days)). The study lists 11 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 2 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.