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A Phase I Study of JLM019 Injection

NCT07623850 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-06-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

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).

Sponsors & Collaborators

  • Jecho Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2029-03-14
Completion
2029-07-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623850 on ClinicalTrials.gov