Study of LM-302 in Patients With Advance Solid Tumors

NCT05161390 | Completed Phase 1

• 1 other identifier: LM302-01-102
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period

  Cycle 1 of each cohort. Duration of one cycle is 21 days

• Adverse Events and Serious Adverse Events

  The safety profile of LM-302 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  From signing the ICF until 28 days after EOT or accept other anti-cancer therapy

• Recommended Phase II Dose (RP2D)

  The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data

  up to 21 days following first dose

• Maximum Tolerated Dose (MTD)

  The MTD is defined as the dose of which the toxicity rate during the DLT observation period (21 days after the first administration in cycle 1 on day 1).

  up to 21 days following first dose

Secondary Outcomes (1)

• Area under plasma concentration vs time curve (AUC) for LM-302

  Up to finished cycle 5 (each cycle is 21 days)

Study Arms (2)

LM-302 Dose Escalation at different dose levels

EXPERIMENTAL

LM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I.

Drug: LM-302 Injection

LM-302(RP2D) Dose Expansion

EXPERIMENTAL

LM-302 Dose Expansion, RP2D will be selected for dose expansion, with the aim to further evaluate the preliminary anti-tumor activity, safety and tolerability, etc.

Drug: LM-302 Injection

Interventions

LM-302 Injection DRUG

LM-302 Injection with dose escalation stage of different dose levels, as well as dose expansion stage with recommended dose level from dose escalation stage.

LM-302 Dose Escalation at different dose levels; LM-302(RP2D) Dose Expansion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure;
• Aged between 18 to 80 years old, male or female when sign the Informed consent form (ICF);
• ECOG score 0-1;
• Life expectancy ≥ 3 months;
• Subjects have histological or cytological confirmation of advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy;
• Claudin18.2(CLDN18.2) status will be tested by immunohistochemistry (IHC) by central lab, the result must be positive;
• At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;
• Subjects must have the following organ and marrow function in laboratory tests within 7 days prior to the first dose;
• Subjects who are able to well communicate with investigators as well as understand and adhere to the requirements of this study.

You may not qualify if:

• Subjects will be excluded from the study, if they meet any of the following criteria:
• Participate in any other clinical trial within 28 days prior to 1st dosing of LM-302;
• Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
• Any adverse event from prior anti-tumor therapy has not yet recovered to ≤grade 1 of CTCAE v5.0;
• Peripheral sensory or motor neuropathy ≥ grade 2;
• Subjects with uncontrolled tumor-related pain;
• Subjects with known central meningeal metastasis;
• Subjects with known brain metastasis, stable brain metastasis judged by investigator can be included;
• Subjects with known antibody drug allergy ≥ grade 3;
• Subjects who have received the treatment with ADCs targeting to CLDN18.2;
• Subjects who were intolerable to the treatment with MMAE based ADCs or anti-CLDN18.2 antibodies are not eligible;
• Administrate strong inhibitors/strong inducers of CYP3A4 within 14 days prior to 1st dosing of LM-302;
• Use of any live vaccines within 28 days prior to 1st dosing of LM-302;
• Subjects with the history of interstitial lung disease or drug-induced interstitial lung disease/pneumonitis;
• Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists (except preventive treatment at a stable dose);

Sponsors & Collaborators

• LaNova Medicines Zhejiang Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jin Li

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

• Wei Shen

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yuping Sun

  Shandong Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yanqiao Zhang

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Jianping Xiong

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Wenhui Lou

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 17, 2021
• Study Start: November 26, 2021
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CN (1)