NCT04735796

Study of LM-102 in Subjects in Advanced Tumors

A Phase I, First-in-Human, Open-Label, Dose Escalation Study of LM-102 Injection in Subjects With CLDN18.2-Positive Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: LaNova Medicines Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ⅰ, first-in-human, open-label, dose escalation study to evaluate the safety and tolerability, PK, immunogenicity and preliminary anti-tumor activity of LM-102 injection in subjects with CLDN18.2-positive advanced solid tumors.

Detailed description

This is a phase Ⅰ, first-in-human, open-label, dose escalation study to evaluate the safety and tolerability, PK, immunogenicity and preliminary anti-tumor activity of LM-102 injection in subjects with CLDN18.2-positive advanced solid tumors. Dose Escalation Traditional '3+3' escalation design will be used. Dose escalation consists of five ascending dose levels of LM-102 (3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg and 40 mg/kg). All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-102 as a 2 h (120±10 min) intravenous (IV) infusion until the disease progression, intolerance, subject discontinuation/informed consent withdrawal, or at the discretion of the investigator in consultation with sponsor. After all the subjects in each cohort complete the DLT assessment, the safety monitor committee (SMC) will make decisions for dose escalations, exploring intermediate/higher doses or terminating dose escalations according to the safety, tolerability, PK and immunogenicity data. The SMC may also adjust the dosage, frequency of administration, PK sample collection plan, etc. Based upon safety, tolerability, PK, and immunogenicity, the MTD or OBD will be determined by SMC. And the RP2D will be determined based on DLTs, MTD or OBD, and the totality of the safety data throughout the study, including dose modifications and delays, PK, and immunogenicity data, etc. The study will consist of 3 periods: 1. Screening period (up to 28 days before the first dose); 2. Treatment period; 3. Follow-up period \[28 (±3) days after end of treatment (EOT)/early withdrawal or before other anti-tumor treatments (whichever occurs earlier)\]. Safety, tolerability and anti-tumor activity evaluation of LM-102 will be conducted throughout the study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Drug：LM-102	Traditional '3+3' escalation design will be used. Dose escalation consists of five ascending dose levels of LM-102 (3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg and 40 mg/kg). All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-102 as a 2 h (120±10 min) intravenous (IV) infusion until the disease progression, intolerance, subject discontinuation/informed consent withdrawal, or at the discretion of the investigator in consultation with sponsor, at most till by one year.

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2021-02-03
• Last updated: 2022-10-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study