Advanced Solid TumorPhase 1NCT04689100
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
A Phase 1 study testing JMT101 in people with Advanced Solid Tumor, run by Shanghai JMT-Bio Inc. at 9 sites in China.
Trial summary
This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- JMT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 9 sitesChina
- Study dates
- 11 Apr 2017to 30 Jun 2022
- 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
- Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
- Stable for more than 14 days of brain metastasis or spinal cord compression.
Who cannot join
- Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
- The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
- Known hypersensitivity to any ingredient of JMT101 or their excipients;
- Major surgery within prior 4 weeks of first treatment.
- Receiving an investigational product in another clinical study within 4 weeks;
- History of serious systemic diseases;
- Pregnancy or lactating wo
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Luhe Hospital. Capital Medical University
Beijing
Dong Yan
- Recruiting
Peking University Cancer Hospital
Beijing
Lin Shen, 8010-88196561, linshenpku@163.com
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu
Jun Qian
Jun Qian
- Recruiting
The First People's Hospital of Changzhou
Changzhou
Wenwei Hu
- Recruiting
Chongqing University Cancer Hospital
Chongqing
Weiqi Nian
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou
Yanhong Deng
- Recruiting
Zhongshan Hospital
Shanghai
Tianshu Liu
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Weichang Chen
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Jufeng Wang
About this study
Official title: A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
Read the detailed description
The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
- Conditions
- Advanced Solid Tumor
- Being tested
- JMT101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101Drug
Also called FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);
Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)
JMT101Drug
Also called FOLFIRI; mFOLFOX6; Irinotecan;
IV infusion Q2W (28-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design.
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days). Receives: Drug: JMT101 |
| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. Receives: Drug: JMT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).
Measured: From enrollment until 30 days after the last dose
Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
Measured: Time from the first dose of study drug up to 4 weeks
Maximum Tolerated Dose (MTD)
Measured: 28 days
Secondary outcomes (10)
Objective Response Rate (ORR)
Measured: From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Measured: From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Measured: From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Measured: From first dose to death or end of study, an average of 1 year
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Measured: From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Measured: From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Measured: From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Measured: From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA) and neutralizing antibodies by electrochemical luminescence(ECL).
Measured: From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma or tumor issue DNA.
The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.
Measured: From enrollment up to disease progression, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start11 Apr 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- 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
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiugao Yang, Study chair, Department of Medicine, CSPC Clinical Development Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689100
- Sponsor's protocol ID
- JMT101-ECL
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 30 Dec 2020
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
- ClinicalTrials.gov ID
- NCT04689100
- Acronym / sponsor ID
- JMT101-ECL
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Dec 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.
This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
Detailed description
The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: JMT101Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days). |
| Dose Expansion Cohort | Experimental | Drug: JMT101Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
- Stable for more than 14 days of brain metastasis or spinal cord compression.
Key exclusion criteria (7 listed)
- Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
- The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
- Known hypersensitivity to any ingredient of JMT101 or their excipients;
- Major surgery within prior 4 weeks of first treatment.
- Receiving an investigational product in another clinical study within 4 weeks;
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 |
|---|---|---|
| JMT101Also: FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) | Drug | Dose Escalation Cohort |
| JMT101Also: FOLFIRI; mFOLFOX6; Irinotecan;IV infusion Q2W (28-day cycles) | Drug | Dose Expansion Cohort |
Primary outcome
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)).
Time frame: From enrollment until 30 days after the last dose
Number of Subjects Experiencing DLTs (Dose Limiting Toxicity).
Time frame: Time from the first dose of study drug up to 4 weeks
Maximum Tolerated Dose (MTD)
Time frame: 28 days
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Time frame: From first dose to death or end of study, an average of 1 year
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
Time frame: From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma or tumor issue DNA.
Time frame: From enrollment up to disease progression, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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.
Xiugao Yang study chair
Department of Medicine, CSPC Clinical Development Division
9 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 JMT101 in people with Advanced Solid Tumor, run by Shanghai JMT-Bio Inc. at 9 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 4 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Xiugao Yang (8021-60677906, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03)). (time frame: From enrollment until 30 days after the last dose). The study lists 3 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 30 Dec 2020.