Solid TumorPhase 1NCT04366648
Safety, Tolerability and Pharmacokinetics of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor
A Phase 1 study testing JK-1201I in people with Solid Tumor, run by JenKem Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- JK-1201I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2018to 31 Mar 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
- 18 to 70 years of age (inclusive)；
- Body mass index (BMI) within the range of 19-30 (inclusive)
- Patient with a malignant solid tumor that has been confirmed by histopathology and/or cytology to be ineffective in conventional treatment or lack effective treatment。 Primary tumors include colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer and advanced breast cancer patients with brain metastases
- More than 4 weeks after the completion of previous anti-tumor therapy (including chemotherapy/radiotherapy, surgical treatment, targeted therapy, immunotherapy, Chinese herbal medicine therapy, endocrine therapy or other anti-tumor therapy), And it has recovered from the adverse reactions of previous treatments (treatment-related toxicity grade ≤1);
- At least one measurable or evaluable lesion was identified using RECIST 1.1;
- Physical state score (ECOG PS score) 0~1
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- Estimated survival time ≥ 3 months
- Both standard blood tests and Blood Biochemistry tests are within normal range.
- All subjects and their partners have no plan to have children from screening to 6 month after the trial, and those who agree to use effective non-drug contraceptive methods during the trial period (e.g., condoms， etc.), those already have permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.
- Voluntarily participate in clinical research and sign informed consent
Who cannot join
- Patients with previous allergy history and known severe allergy to injectable PEG-Irinotecan or any excipient of the product;
- Have received HCl-Irinotecan (CPY-11) treatment in the past
- With active brain metastasis;
- Have other malignant tumors within 5 years before enrollment, except for previously treated with the purpose of radical cure such as carcinoma in situ of the cervix, squamous cell carcinoma or basal cell carcinoma
- Large amount of thorax and ascites that need treatment
- Serious cardiovascular disease, including grade II and above cardiac dysfunction (NYHA standard)
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- Active hepatitis b (HBsAg and/or HBCAb positive, peripheral blood HBV DNA titer test ≥1×103 IU/mL, or hepatitis c patients; or testing positive for syphilis or human immunodeficiency virus (HIV);
- Subject is participating in other clinical studies or the presumed first time of drug administration is less than 4 weeks from the end of the previous clinical study (last administration or 5 half-lives of the previous study drug);
- Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs (interferon, interleukin, etc.) with immune-stimulatory effects within 28 days before the assumed first medication
- Subjects who had a severe infection within 4 weeks before the first medication， including but not limited to complications of infection, bacteremia, severe pneumonia and others requiring hospital stays;
- Patient has electrolyte disorder with clinically significance
- Subject has clinically severe gastrointestinal disorders, (positive fecal occult blood with severe gastrointestinal bleeding, gastrointestinal infection, obstruction or diarrhea of grade 1 or above on endoscopic examination (the number of stool increases ≥4 times per day))
- Patients with bleeding tendency or receiving thrombolytic or anticoagulant therapy
- Within 14 days before receiving the study drug treatment subject have used a strong CYP3A4 inducer (Phenytoin or Carbamazepine, Barbiturates, Rifampicin or Rifabutin, Hypericum perforatum, etc.);
- Within 7 days prior drug treatment, patients have used strong CYP3A4 inhibitors (Clarithromycin, Ketoconazole or Itraconazole, Indinavir, Lopinavir, Nafazodone, Nelfinavir, Ritonavir, Saquinavir, Trapavir, Voriconazole, etc.)
- Within 7 days before receiving study drug treatment, subject has used strong UGT1A1 inhibitors (Atazanavir, Gemfibrozil, etc.)
- Clear history of neuropathy or mental disorders (including epilepsy or dementia)
- Persons with a history of alcohol or drug abuse
- Pregnant or lactating women
- Investigator considered the subject who are not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
The fifth medical center of PLA general hospital
Beijing, Beijing Municipality, 100071
About this study
Official title: Study on the Safety, Tolerability and Pharmacokinetics of Single and Multiple Administration of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor
The purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors
Read the detailed description
This study is a multicenter, open labeled, positive controlled, single, -combined, with multiple dose escalation trial.
The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2, 125mg/m2, 150mg/m2 and 180mg/m2 respectively. At each testing dose group, one patient will be treated with HCl-Irinotecan (CPT-11), at dose level of 175mg/m2.
The initial dose of 50mg /m2 will be administered once. Starting from the 75mg/m2 dose group, each patient will be given testing drug at least twice. During first and second drug administration, blood samples will be collected for PK characteristics analysis. Patients will be evaluated after every two rounds of drug delivery and preliminary efficacy of testing compound will be determined as PD, SD, CR etc.
- Conditions
- Solid Tumor
- Being tested
- JK-1201I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK-1201IDrug
malignant solid tumor that has been confirmed by histopathology and/or cytology
| Study group | Role | What they receive |
|---|---|---|
| 50mg/m2 | Experimental | Starting dose, administered once only Receives: Drug: JK-1201I |
| 75mg/m2 | Experimental | Second dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. Receives: Drug: JK-1201I |
| 100mg/m2 | Experimental | Third dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. Receives: Drug: JK-1201I |
| 125mg/m2 | Experimental | Forth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. Receives: Drug: JK-1201I |
| 150mg/m2 | Experimental | Fifth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. Receives: Drug: JK-1201I |
| 180mg/m2 | Experimental | Sixth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. Receives: Drug: JK-1201I |
| 175mg/m2 | Active comparator | CPT-11, given every 14 days, first 2 cycles of drug delivery will accompanied with PK test, Receives: Drug: JK-1201I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome 1
Maximum tolerance dose (MTD) will be determined. MTD is defined as the highest dose that can be given without causing any adverse side effects according to CTCAE v5.0.
The dose climbing scheme was designed according to the improved Fibonacci method, which was carried out in sequence from the low dose group to the high dose group. The principle of "3+3" dose increment was adopted. At least 4 subjects were randomly enrolled in each dose group (including one patient who will be assigned to control drug).
Measured: 21 days
Primary outcome 2
Dose limited toxicity (DLT) of injectable PEG -Irinotecan in patients will be determined.
DLT is defined as: 1..Grade 4 neutropenia (ANC) reduction lasts ≥3 days; or grade 3 ANC reduction with fever (ANC <1000 / mm3 with oral temperature single measurement> 38.3 ℃ or ≥38.0 ℃ for 1 hour)； 2. Grade 3 thrombocytopenia (25×109/L≤ platelet count < 50×109/L) with obvious clinical bleeding symptoms, or grade 4 thrombocytopenia (with or without obvious clinical bleeding symptoms); 3. Other grade 4 hematological toxicity； 4. Grade 3 and above non-hematological toxicity； 5. Hair loss, fatigue, except for those with grade 3 nausea, vomiting, and diarrhea without maximum symptomatic supportive treatment.
Measured: 21 days
Secondary outcomes (2)
Secondary outcome 1
Serum concentration of injectable PEG-Irinotecan , Irinotecan and SN-38 in human subjects.
Blood samples will be taken within 60min before administration, 10min±5min after intravenous infusion, 10min±5min before the end of intravenous infusion, immediately after intravenous infusion 0h±5min, thereafter 15min±5min, 30min±5min, 1h±5min, 2h±10min, 4h±15min, 8h±30min, 12h±30min, 24h±1h, 48h±2h, 72h±2h, 96h±2h, 168h±2h; A total of 16 time points were collected in each patient. The concentrations of PEG-Irinotecan, irinotecan and the active metabolite SN-38 will be determined by LC-MS/MS. And the maximum concentration (Cmax) and the time of peak of concentration (Tmax) will be compared across different groups.
Measured: 21 days
Secondary outcome 2
Objective Response Rate (ORR) of injectable PEG-Irinotecan in patients. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start4 May 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study is a multicenter, open labled, positive controled, single, -combined, with multiple dose escalation trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- JenKem Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuan Zhao, Ph.D., Study chair, JenKem Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366648
- Sponsor's protocol ID
- JK-1201I-P1
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2020
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Long J, Li X, Wu L, Yu G, Zang A, Zhao Y, Shi J, Nie L, Zhao X, Fang J. Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second-line monotherapy for patients with small-cell lung cancer. Cancer Med. 2024 Sep;13(17):e70059. doi: 10.1002/cam4.70059.
PubMed 39225504
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety, Tolerability and Pharmacokinetics of Single and Multiple Administration of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT04366648
- Acronym / sponsor ID
- JK-1201I-P1
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- JenKem Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Apr 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 purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors
Detailed description
This study is a multicenter, open labeled, positive controlled, single, -combined, with multiple dose escalation trial.
The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2, 125mg/m2, 150mg/m2 and 180mg/m2 respectively. At each testing dose group, one patient will be treated with HCl-Irinotecan (CPT-11), at dose level of 175mg/m2.
The initial dose of 50mg /m2 will be administered once. Starting from the 75mg/m2 dose group, each patient will be given testing drug at least twice. During first and second drug administration, blood samples will be collected for PK characteristics analysis. Patients will be evaluated after every two rounds of drug delivery and preliminary efficacy of testing compound will be determined as PD, SD, CR etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- This study is a multicenter, open labled, positive controled, single, -combined, with multiple dose escalation trial.
| Arm | Type | Receives |
|---|---|---|
| 50mg/m2 | Experimental | Drug: JK-1201IStarting dose, administered once only |
| 75mg/m2 | Experimental | Drug: JK-1201ISecond dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. |
| 100mg/m2 | Experimental | Drug: JK-1201IThird dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. |
| 125mg/m2 | Experimental | Drug: JK-1201IForth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. |
| 150mg/m2 | Experimental | Drug: JK-1201IFifth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. |
| 180mg/m2 | Experimental | Drug: JK-1201ISixth dose level, administered at least twice, first two cycles of drug delivery accompanied with PK analyses. |
| 175mg/m2 | Active comparator | Drug: JK-1201ICPT-11, given every 14 days, first 2 cycles of drug delivery will accompanied with PK test, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 to 70 years of age (inclusive)；
- Body mass index (BMI) within the range of 19-30 (inclusive)
- Patient with a malignant solid tumor that has been confirmed by histopathology and/or cytology to be ineffective in conventional treatment or lack effective treatment。 Primary tumors include colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer and advanced breast cancer patients with brain metastases
- More than 4 weeks after the completion of previous anti-tumor therapy (including chemotherapy/radiotherapy, surgical treatment, targeted therapy, immunotherapy, Chinese herbal medicine therapy, endocrine therapy or other anti-tumor therapy), And it has recovered from the adverse reactions of previous treatments (treatment-related toxicity grade ≤1);
- At least one measurable or evaluable lesion was identified using RECIST 1.1;
Key exclusion criteria (20 listed)
- Patients with previous allergy history and known severe allergy to injectable PEG-Irinotecan or any excipient of the product;
- Have received HCl-Irinotecan (CPY-11) treatment in the past
- With active brain metastasis;
- Have other malignant tumors within 5 years before enrollment, except for previously treated with the purpose of radical cure such as carcinoma in situ of the cervix, squamous cell carcinoma or basal cell carcinoma
- Large amount of thorax and ascites that need treatment
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 |
|---|---|---|
| JK-1201Imalignant solid tumor that has been confirmed by histopathology and/or cytology | Drug | 100mg/m2, 125mg/m2, 150mg/m2, 175mg/m2, 180mg/m2, 50mg/m2, 75mg/m2 |
Primary outcome
Primary outcome 1
Time frame: 21 days
Maximum tolerance dose (MTD) will be determined. MTD is defined as the highest dose that can be given without causing any adverse side effects according to CTCAE v5.0. The dose climbing scheme was designed according to the improved Fibonacci method, which was carried out in sequence from the low dose group to the high dose group. The principle of "3+3" dose increment was adopted. At least 4 subjects were randomly enrolled in each dose group (including one patient who will be assigned to control drug).
Primary outcome 2
Time frame: 21 days
Dose limited toxicity (DLT) of injectable PEG -Irinotecan in patients will be determined. DLT is defined as: 1..Grade 4 neutropenia (ANC) reduction lasts ≥3 days; or grade 3 ANC reduction with fever (ANC <1000 / mm3 with oral temperature single measurement> 38.3 ℃ or ≥38.0 ℃ for 1 hour)； 2. Grade 3 thrombocytopenia (25×109/L≤ platelet count < 50×109/L) with obvious clinical bleeding symptoms, or grade 4 thrombocytopenia (with or without obvious clinical bleeding symptoms); 3. Other grade 4 hematological toxicity； 4. Grade 3 and above non-hematological toxicity； 5. Hair loss, fatigue, except for those with grade 3 nausea, vomiting, and diarrhea without maximum symptomatic supportive treatment.
2 secondary outcomes
Secondary outcome 1
Time frame: 21 days
Secondary outcome 2
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 39225504Long J, Li X, Wu L, Yu G, Zang A, Zhao Y, Shi J, Nie L, Zhao X, Fang J. Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second-line monotherapy for patients with small-cell lung cancer. Cancer Med. 2024 Sep;13(17):e70059. doi: 10.1002/cam4.70059.
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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.
Xuan Zhao, Ph.D. study chair
JenKem Technology Co., Ltd.
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 JK-1201I in people with Solid Tumor, run by JenKem Technology 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 20 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: finished, as of the sponsor's last update on 4 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome 1 (time frame: 21 days). The study lists 2 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 NCT04366648, which also lists 1 linked publication.
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 4 Sep 2024.