A Phase I Study of JLM019 Injection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJecho Biopharmaceuticals Co., Ltd.
About this trial
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.
During the dose escalation phase, the dose escalation scheme is the accelerated titration in 0.001 - 0.2 mg/kg cohorts plus a traditional '3 + 3' design in 0.6 - 10 mg/kg cohorts, jointly in nine dose cohorts 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6 and 10 mg/kg. JLM019 Injection is intended to be administered once a week (QW). However, the dose and interval of administration may be adjusted based on the acquired PK, PD, and safety data. Each treatment cycle is 28 days.The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions.
Safety profile, DLT, MTD and RED of JLM019 Injection shall be assessed during and after treatment, with PK, PD, immunogenicity and Efficacy analyzed correspondingly.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eighteen years of age or older;
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 (OV), renal cell carcinoma (RCC), melanoma, biliary tract cancer (BTC), alveolar soft part sarcoma (ASPS), etc.
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.
AST: At least one tumor lesion ≥ 10 mm in the longest diameter as assessed by computed tomography (CT);
Disqualifiers
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;
Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature ≥ 37.5 °C);
Trial design
Design model
Single group
Treatments tested in this trial
JLM019 Injection
Biological/VaccineThe JLM019 Injection will be administered via intravenous (IV) infusion at dose levels of 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6, and 10 mg/kg. Each IV infusion must last at least 30 min. The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions. (Note: The dose and administration interval may be adjusted based on acquired PK, PD and safety data).
Treatment groups
115 Participants
are divided into 1 treatment groupGroup A: JLM019 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with reported Dose-limiting toxicity (DLT)
Evaluate according to the DLT standards specified in the protocol
Time frame
Within 28 days after the first dose2
Rate of adverse events
In accordance with NCI CTCAE v5.0, the toxicity assessment will be conducted
Time frame
Up to 3 years3
Determine the recommended dose for combination for JLM019 injection
Evaluate the data from the Phase Ia study to determine recommended dose for combination for JLM019 injection in Phase Ib
Time frame
Up to 3 yearsSecondary outcomes
1
Determination of JLM019 concentrations
Assays were performed by ELISA at the central laboratory
Time frame
Up to 12 months2
Detection of anti-JLM019 antibodies in serum
Assays were performed by ELISA at the central laboratory
Time frame
Up to 12 months3
Determination of detailed blood lymphocyte subsets
Assays were performed by flow cytometry at the central laboratory
Time frame
Up to 12 months4
Determination of cytokines in blood
Assays were performed by ELISA at the central laboratory
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov