Study of LM-302 in Patients With Advance Solid Tumors

NCT ID: NCT05161390

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-26
• Study Completion Date: 2025-01-10

Brief Summary

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

Detailed Description

A Phase I/II, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors The study includes phase I (dose escalation) to determine MTD/RP2D and phase II (dose expansion) to assess the preliminary anti-tumor activity, etc..

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LM-302 Dose Escalation at different dose levels

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.

Group Type: EXPERIMENTAL

LM-302 Injection

Intervention Type: 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(RP2D) Dose Expansion

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.

Group Type: EXPERIMENTAL

LM-302 Injection

Intervention Type: 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.

Interventions

LM-302 Injection

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Aged between 18 to 80 years old, male or female when sign the Informed consent form (ICF);

3. ECOG score 0-1;

4. Life expectancy ≥ 3 months;

5. Subjects have histological or cytological confirmation of advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy;

6. Claudin18.2(CLDN18.2) status will be tested by immunohistochemistry (IHC) by central lab, the result must be positive;

7. At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;

8. Subjects must have the following organ and marrow function in laboratory tests within 7 days prior to the first dose;

9. Subjects who are able to well communicate with investigators as well as understand and adhere to the requirements of this study.

Exclusion Criteria

Subjects will be excluded from the study, if they meet any of the following criteria:

1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-302;

2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.

3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤grade 1 of CTCAE v5.0;

4. Peripheral sensory or motor neuropathy ≥ grade 2;

5. Subjects with uncontrolled tumor-related pain;

6. Subjects with known central meningeal metastasis;

7. Subjects with known brain metastasis, stable brain metastasis judged by investigator can be included;

8. Subjects with uncontrolled third interstitial effusion judged by the investigator to be unsuitable for inclusion;

9. Subjects with known antibody drug allergy ≥ grade 3;

10. Subjects who have received the treatment with ADCs targeting to CLDN18.2;

11. Subjects who were intolerable to the treatment with MMAE based ADCs or anti-CLDN18.2 antibodies are not eligible;

12. Administrate strong inhibitors/strong inducers of CYP3A4 within 14 days prior to 1st dosing of LM-302;

13. Use of any live vaccines within 28 days prior to 1st dosing of LM-302;

14. Subjects with the history of interstitial lung disease or drug-induced interstitial lung disease/pneumonitis;

15. Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists (except preventive treatment at a stable dose);

16. Uncontrolled persistent and recurrent vomiting (e.g. due to gastric outlet obstruction);

17. Subjects with uncontrolled/severe gastrointestinal hemorrhage, or ulcer within 28 days prior to 1st dosing of LM-302;

18. Subjects who have received surgical or interventional treatment within 28 days prior to 1st dosing LM-302, with the exception for tumor biopsy,puncture, etc.;

19. (Limited PhaseⅡ dose expansion)Subjects who have another active malignancy which is likely to require treatment, and have the history of another malignancy within 2 years before the 1st dosing LM-302;

20. Subjects who have severe cardiovascular disease;

21. Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection requiring antibiotics administration;

22. Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;

23. HIV infection, active HBV and HCV infection;

24. Child-bearing potential female who have positive results in pregnancy test before the 1st dosing LM-302 or are lactating;

25. Subjects who have psychiatric illness or social situations that would preclude study compliance;

26. Subject who is determined as not eligible to participate in this study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LaNova Medicines Zhejiang Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Wei Shen

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Yuping Sun

Role: PRINCIPAL_INVESTIGATOR

Shandong Province Cancer Hospital

Yanqiao Zhang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Jianping Xiong

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Wenhui Lou

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LM302-01-102

Identifier Type: -

Identifier Source: org_study_id