Solid TumorPhase 1NCT06239623
ERK Inhibitor JSI-1187 in Advanced Solid Tumors
A Phase 1 study testing JSI-1187 in people with Solid Tumor and NSCLC, run by JS InnoPharm, LLC at 1 site in China.
Trial summary
JSI-1187-101 phase 1 study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, NSCLC, Melanoma
- What is being tested?
- JSI-1187
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2022to 30 Dec 2024
- 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
- Age of both sexes ranged from 18 to 75 years (inclusive of 18 and 75 years old).
- For dose escalation phase only:
- Patients with locally advanced or metastatic solid tumors with histologically or cytologically confirmed MAPK signaling pathway mutations who are unresponsive to standard treatment regimens or for whom no standard treatment regimens are available;
- Only in the extension stage (all the following conditions must be met):
- Patients who have histologically or cytologically confirmed, locally advanced or metastatic solid tumors with the following MAPK signaling pathway mutations that do not respond to or have no standard treatment options:
- Locally advanced or metastatic head and neck cancer, melanoma, small bowel cancer, bile duct cancer, and gallbladder cancer with BRAF non-V600 (G469, L597, L485, etc.) mutation (approximately 10-30 cases, subject number adjusted according to efficacy); Locally advanced or metastatic colorectal cancer, cholangiocarcinoma, gallbladder cancer, small bowel cancer or other solid tumors with BRAF V600 E mutation (approximately 10-20 cases, of which colorectal cancer is expected to be 3-6 cases, the number of subjects will be adjusted according to efficacy); KRAS G12V-mutated, locally advanced or metastatic non-small- cell lung cancer (approximately 10 patients, adjusted for the number of participants according to efficacy).
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- ECOG performance status (Appendix 2) is 0-2.
- Life expectancy of ≥12 weeks.
- patients should have adequate end-organ function, with laboratory results 7 days before the first dose meeting the following requirements: Bone marrow reserve: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L, and hemoglobin ≥90 g/L;(no use of hematopoietic stimulating factors such as EPO, G-CSF or GM-CSF in the 14 days before the test, and no blood transfusion in the 14 days before the test) Liver function: serum albumin ≥3.0 g/dL; Total bilirubin ≤1.5× upper limit of normal value (ULN), ALT and AST≤ 2×ULN, if liver metastasis or liver cancer patients, ALT or AST≤3×ULN; Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥60 mL per minute (according to the Cockcroft-Gault formula; see Appendix 3); Coagulation function: INR≤1.5×ULN, APTT ≤1.5×ULN.
- Cardiac function: left ventricular ejection fraction (LVEF)≥50%.
- Female or male participants of childbearing age and their partners are required to use a medically approved contraceptive method (Annex 4) during the study treatment period and for 3 months after the end of the study treatment period if the women of childbearing age (defined as those younger than 50 years old or older than 50 years of age who are amenorrheic for less than 12 months before screening) tested negative for serum β-HCG.
- Participants are required to provide informed consent for the study and to sign an informed consent form before the trial.
- At least one measurable lesion was present according to RECIST 1.1 criteria
Who cannot join
- Patients with a history of allergy to any component of JSI-1187 or its pharmaceutical excipients.
- Patients with prolonged QTcF (QTcF: male \>450 ms, female \>470ms, QTcF formula is shown in Appendix 5).
- Patients who has previously received other ERK inhibitors.
- Active central nervous system tumors or central nervous system metastases, as indicated by clinical symptoms, cerebral edema, need for systemic hormone use, and disease progression. Patients with treated tumors or metastases of the central nervous system are eligible if they have been clinically stable (as determined by imaging or other clinical testing) for at least 8 weeks and if they had stopped immune suppressive systemic hormones (\> 10 mg per day of prednisone or equivalent) for at least 4 weeks before the first dose of study drug.
- Patients with basal-cell, squamous-cell, or carcinoma in situ are excluded if they had a history of other malignancies within 2 years before enrollment, have undergone potentially curative treatment, and have been free of disease recurrence for 5 years after the initiation of treatment.
- History of or current evidence/risk of retinal vein occlusion or central serous retinopathy.
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- Have received antineoplastic therapy within 28 days before the first dose, including but not limited to: chemotherapy, biotherapy, radiotherapy (except palliative radiotherapy for patients with bone metastases), endocrine therapy, targeted antineoplastic therapy (except nitrosourea and mitomycin C); Received nitrosourea or mitomycin C within 6 weeks before the first dose. Had received treatment with a traditional Chinese medicine with definite antitumor effects within 14 days before the first dose. Except for alopecia and eligibility criteria, radiation-related toxicities (including radiodermatitis dermatitis, post-radiation recall reactive dermatitis, soft tissue fibrosis, etc.) did not recover to grade 1 or lower (according to CTCAE 5.0) after palliative radiotherapy in patients with bone metastases.
- Patients have received other drugs which are still in clinical trials within 28 days before the first dose.
- Patients who has undergone major surgical procedures or has active ulcers (which are still present) or wounds that do not fully heal within 28 days before the first dose.
- Chronic systemic comorbidities (e.g., severe chronic lung, liver, kidney, or heart disease) that cannot be controlled (have received active treatment but is not currently stable or may progress/relapse during the trial).
- Patients with severe cardiac disease, such as uncontrolled arrhythmia, myocardial infarction, unstable angina, or New York Heart Association (NYHA) class III-IV cardiac dysfunction, within 6 months prior to the first dose (Annex 6).
- Patients who have factors that increase the risk of QTc prolongation and the risk of arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden death of an immediate family member under 40 years of age from an unknown cause, and taking any concomitant medications that cause prolongation of the QT interval (Appendix 7).
- Patients with uncontrolled (actively treated but not currently stable or with potential disease progression/recurrence during the trial) body fluid (pleural effusion, pericardial effusion, or ascites).
- Patients who are in the acute phase of infection and require medical therapy.
- Unable to swallow capsules or suffering from a condition that significantly affects gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
- Patients who are taking (or could not be discontinued 2 weeks before the first dose) any known strong inhibitor or strong inducer of CYP3A4, BCRP substrate, or who needed to continue receiving these drugs during the study (Appendix 8).
- Positive human immunodeficiency virus antibody (HIV-Ab) within 1 week before the first dose; Or HCV antibody (HCV-Ab) positive and HCV RNA quantification \> the upper limit of normal value of the detection unit;Or patients with positive hepatitis B surface antigen (HBsAg) and HBV DNA \> the upper limit of normal value.
- The presence of serious psychological or psychiatric abnormalities that affect the patient\'s compliance to participate in this clinical study.
- Patients with a history of psychotropic substance abuse or drug use.
- Patients with adverse event worse than CTCAE1 that is not resolved due to previous antineoplastic therapy before the first dose (except alopecia, sensory neuropathy, and eligibility criteria otherwise required).
- Women who are lactating.
- Any other condition judged by the investigator to be inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Dr.Wang, +86 10 88121122, 8421cn@21cn.com
Zhenghang Wang, PhD
About this study
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JSI-1187 Capsule in the Treatment of Advanced Solid Tumors With MAPK Signaling Pathway Mutations
JSI-1187-101 phase 1 study
Read the detailed description
This study is a multicenter, open-label, dose-escalation and dose- expansion phase I clinical study. To investigate the safety, tolerability and PK characteristics of JSI-1187 capsule in Chinese patients with advanced solid tumors harboring MAPK signaling pathway mutations, and to evaluate the efficacy of JSI-1187 capsule in the treatment of advanced solid tumors harboring MAPK signaling pathway mutations.
- Conditions
- Solid Tumor, NSCLC, Melanoma
- Being tested
- JSI-1187
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSI-1187Drug
Use ERK inhibitor JSI-1187 to treat solid tumor
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | ERK inhibitor JSI-1187 Receives: Drug: JSI-1187 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Measured: through study completion, an average of 1 year
Serious Adverse Events
Any untoward medical occurrence that at any dose:results in death、is life-threatening、requires inpatient hospitalization or prolongation of existing hospitalization、results in persistent or significant disability/incapacity,or is a congenital anomaly/birth defect
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Objective Response Rate
The proportion of patients with complete and partial responses.
Measured: through study completion, 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 posted2 Feb 2024
- Study start2 Apr 2022
- Primary completion28 Sep 2024 (estimated)
- Study completion30 Dec 2024 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JS InnoPharm, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, PhD, Principal investigator, Beijing Cancer Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239623
- Sponsor's protocol ID
- JSI-1187-101
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JSI-1187 Capsule in the Treatment of Advanced Solid Tumors With MAPK Signaling Pathway Mutations
- ClinicalTrials.gov ID
- NCT06239623
- Acronym / sponsor ID
- JSI-1187-101
- Conditions
- Solid Tumor, NSCLC, Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- JS InnoPharm, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 28 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
JSI-1187-101 phase 1 study
Detailed description
This study is a multicenter, open-label, dose-escalation and dose- expansion phase I clinical study. To investigate the safety, tolerability and PK characteristics of JSI-1187 capsule in Chinese patients with advanced solid tumors harboring MAPK signaling pathway mutations, and to evaluate the efficacy of JSI-1187 capsule in the treatment of advanced solid tumors harboring MAPK signaling pathway mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: JSI-1187ERK inhibitor JSI-1187 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age of both sexes ranged from 18 to 75 years (inclusive of 18 and 75 years old).
- For dose escalation phase only:
- Patients with locally advanced or metastatic solid tumors with histologically or cytologically confirmed MAPK signaling pathway mutations who are unresponsive to standard treatment regimens or for whom no standard treatment regimens are available;
- Only in the extension stage (all the following conditions must be met):
- Patients who have histologically or cytologically confirmed, locally advanced or metastatic solid tumors with the following MAPK signaling pathway mutations that do not respond to or have no standard treatment options:
Key exclusion criteria (22 listed)
- Patients with a history of allergy to any component of JSI-1187 or its pharmaceutical excipients.
- Patients with prolonged QTcF (QTcF: male \>450 ms, female \>470ms, QTcF formula is shown in Appendix 5).
- Patients who has previously received other ERK inhibitors.
- Active central nervous system tumors or central nervous system metastases, as indicated by clinical symptoms, cerebral edema, need for systemic hormone use, and disease progression. Patients with treated tumors or metastases of the central nervous system are eligible if they have been clinically stable (as determined by imaging or other clinical testing) for at least 8 weeks and if they had stopped immune suppressive systemic hormones (\> 10 mg per day of prednisone or equivalent) for at least 4 weeks before the first dose of study drug.
- Patients with basal-cell, squamous-cell, or carcinoma in situ are excluded if they had a history of other malignancies within 2 years before enrollment, have undergone potentially curative treatment, and have been free of disease recurrence for 5 years after the initiation of 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 |
|---|---|---|
| JSI-1187Use ERK inhibitor JSI-1187 to treat solid tumor | Drug | Experimental |
Primary outcome
Adverse Event
Time frame: through study completion, an average of 1 year
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Serious Adverse Events
Time frame: through study completion, an average of 1 year
Any untoward medical occurrence that at any dose:results in death、is life-threatening、requires inpatient hospitalization or prolongation of existing hospitalization、results in persistent or significant disability/incapacity,or is a congenital anomaly/birth defect
1 secondary outcome
Objective Response Rate
Time frame: through study completion, 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 2 Feb 2024.
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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.
Lin Shen, PhD principal investigator
Beijing Cancer Hosptial
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 JSI-1187 in people with Solid Tumor and NSCLC, run by JS InnoPharm, LLC 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 13 inclusion and 22 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 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JSI trial (+86 2158381698, yuqin.xi@jsinnopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: through study completion, an average of 1 year). 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?
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 Feb 2024.