A Phase I Study of JLM019 Injection

Sponsor
Jecho Biopharmaceuticals Co., Ltd.
Study ID
NCT07623850
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JLM019 Injection — BIOLOGICAL
    The 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).

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Jan 13, 2026
Status verified
May 2026
Primary completion
Mar 14, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JLM019 Injection
    The 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).

Primary Outcome Measure

Number of participants with reported Dose-limiting toxicity (DLT) [ Time Frame: Within 28 days after the first dose ]

Central Contacts

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