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New treatment option for Advanced Solid Tumor (Phase 1)
Official title A Phase I Study of JLM019 Injection
ClinicalTrials.gov ID: NCT07623850
What this study is testing
What is JLM019 Injection?
JLM019 Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced solid tumor (phase 1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, single-arm, open-label, dose escalation phase (Part A) and dose expansion (Part B) study to evaluate the safety and tolerability of JLM019 Injection in patients with advanced malignancies. The study subjects are adults with advanced malignancies including advanced solid tumors or relapsed/refractory lymphoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eighteen years of age or older;
- Patients with histopathologically or cytologically confirmed advanced solid tumors (AST) or relapsed/refractory (r/r) Hodgkin's/Non-Hodgkin's...
- AST subtypes include but are not limited: colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC)...
- HL/NHL subtypes include but are not limited: classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma...
- Measurable disease as defined as:
You likely can't join if
- Allergy to JLM019 Injection components;
- History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous monoclonal antibody or other Fc-based protein therapy;
- Experienced any cardiovascular immune-related adverse event (irAE), or discontinued from that treatment due to a Grade 3 or higher irAE in previous...
- Any serious or uncontrolled health conditions listed below:
- Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature...
- History of vascular diseases within the past 6 months (including myocardial infarction, unstable angina, cerebrovascular diseases, and peripheral...
See the full eligibility criteria
Who can join
- Eighteen years of age or older;
- Patients with histopathologically or cytologically confirmed advanced solid tumors (AST) or relapsed/refractory (r/r) Hodgkin's/Non-Hodgkin's lymphomas (HL/NHL, including transformed lymphomas):
- AST subtypes include but are not limited: colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), gastric cancer (GC), ovarian cancer...
- HL/NHL subtypes include but are not limited: classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), mantle cell lymphoma (MCL), etc.
- Measurable disease as defined as:
- AST: At least one tumor lesion ≥ 10 mm in the longest diameter as assessed by computed tomography (CT);
- HL/NHL: Fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) and ≥ 1 lesion \> 15 mm in the longest diameter by \> 10 mm in the short axis, as assessed by CT;
- Patients with the following molecular profiles will be prioritized for enrollment:
- High tumor T-cell infiltration (e.g., elevated T-cell GEP score);
- TMB \> 10 mut/Mb、MSI-H/dMMR status or POLE/POLD1 mutations. Absence of β2M and JAK1/JAK2 loss-of-function mutations.
- Submission of tumor biopsy representative of the current disease, which may consist of any of the following:
- Archived formalin-fixed paraffin-embedded (FFPE) tissue block;
- At least 15-20 slides of tumor tissue from an FFPE block suitable for immunohistochemistry (IHC), including ≥ 10 % tumor content per section with ≥ 20 mm2 of evaluable tissue which may include ≤ 50 % tumor adjacent...
- A fresh tumor biopsy obtained by surgical excision or core needle procedure prior to the first dose of JLM019 Injection;
- For patients with accessible tumors, willingness to undergo on-study biopsy as scheduled in the protocol;
- Eastern Cooperative Oncology Group (ECOG) performance status grade 0\~1;
- Life expectancy ≥ 3 months estimated by the Investigator;
- Recovery to Grade ≤ 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to the first dose of investigational product (except alopecia, hearing loss, Grade ≤ 2 neuropathy, or endocrinopathy...
- Adequate baseline hematologic, renal, hepatic, and cardiac function as defined by:
- Lymphocyte ≥ 0.5 × 109/L；
- ANC ≥ 1.5 × 109/L;
- Platelet count (PLT) ≥ 100 × 109/L;
- Hemoglobin (HGB)≥ 90 g/L (no packed red blood cell transfusion within the prior 2 weeks);
- Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2, as calculated by the Modification of Diet in Renal Disease (MDRD) formula;
- ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if there is evidence of hepatic involvement by malignant disease);
- International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy in which PT or aPTT is within therapeutic...
- High sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ ULN (asymptomatic abnormalities may be permitted after clearance by cardiology consultation).
- All patients and their partners must have no plans for conception from screening period and during the trial, and agree to practice effective contraception during the trial and for 4 months after the last dose of JLM019.
- Able to participate and willing to give written informed consent form.
What rules you out
- Allergy to JLM019 Injection components;
- History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous monoclonal antibody or other Fc-based protein therapy;
- Experienced any cardiovascular immune-related adverse event (irAE), or discontinued from that treatment due to a Grade 3 or higher irAE in previous ICI therapy;
- Any serious or uncontrolled health conditions listed below:
- Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature ≥ 37.5 °C);
- History of vascular diseases within the past 6 months (including myocardial infarction, unstable angina, cerebrovascular diseases, and peripheral arterial or aortic diseases);
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least two separate occasions after antihypertensive treatment);
- Individuals with active thrombosis, active bleeding, or pathological conditions associated with high bleeding risk (such as coagulation disorders);
- Has an active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or...
- Any serious or uncontrolled cardiovascular condition, including but not necessarily limited to:
- Any history of myocarditis of any etiology;
- History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within...
- Left ventricular ejection fraction \< 45 % on screening echocardiogram;
- Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such patients may be enrolled...
- History of (non-infectious) pneumonitis / interstitial lung disease or current pneumonitis / interstitial lung disease;
- Presence of any active central nervous system (CNS; brain or leptomeningeal) metastases. Solid tumor patients with CNS metastases are eligible if previously treated and there is no magnetic resonance imaging (MRI)...
- Prior organ allograft or allogeneic hematopoietic stem cell transplantation (HSCT). Lymphoma patients ≥ 3 months post-HSCT with no evidence of active graft versus host disease may be eligible upon approval by the...
- Receipt of any of the following within the timeframes indicated, before first scheduled dose of JLM019 Injection:
- Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab) and Lag-3 (e.g., relatlimab), or costimulatory agonists (including but...
- Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks. Note: for lung cancers or mesotheliomas, radiation therapy to the lung that is \> 30 Gy within 6 months;
- Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody-like drugs, cytokines, cell therapies, or radio immunoconjugates: 4 weeks (2 weeks permissible with documented disease progression...
- Currently participating in another clinical trial or has participated in another clinical trial within 4 weeks prior to the first dose of the investigational study treatment. Note: Patients who have entered the...
- Any condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days of the first dose of JLM019 Injection. Inhaled...
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of JLM019 Injection. Note: Administration of inactivated vaccines is allowed;
- Received radiotherapy within 2 weeks of start of study treatment or had a history of radiation pneumonitis. Note: Patients must have recovered from all radiation-related toxicities, not required corticosteroids, and...
- Any second malignancy active within the previous 3 years( (except adequately treated carcinoma in situ of cervix, basal cell carcinoma or squamous cell skin carcinoma));
- Patients with a history of AIDS, syphilis, or active hepatitis [For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of...
- Pregnancy or lactation, and a woman of childbearing potential (WOCBP) who has a positive pregnancy test (within 7 days) prior to treatment;
- Patients deemed unsuitable for participation in this study at the Investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.