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Study of LM-302 in Patients With Advance Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161390
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : December 30, 2021
Sponsor:
Information provided by (Responsible Party):
LaNova Medicines Limited ( LaNova Medicines Zhejiang Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE December 5, 2021
First Posted Date  ICMJE December 17, 2021
Last Update Posted Date December 30, 2021
Actual Study Start Date  ICMJE November 26, 2021
Estimated Primary Completion Date March 10, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2021)
  • Dose limiting toxicity (DLT) [ Time Frame: Cycle 1 of each cohort. Duration of one cycle is 21 days ]
    DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
  • Adverse Events and Serious Adverse Events [ Time Frame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy ]
    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
  • Recommended Phase II Dose (RP2D) [ Time Frame: up to 21 days following first dose ]
    The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data
  • Maximum Tolerated Dose (MTD) [ Time Frame: up to 21 days following first dose ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2021)
Area under plasma concentration vs time curve (AUC) for LM-302 [ Time Frame: Up to finished cycle 5 (each cycle is 21 days) ]
changes in AUC over time in participants with LM-302
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of LM-302 in Patients With Advance Solid Tumors
Official Title  ICMJE A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours
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..
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: LM-302 Injection
  • Experimental: 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.
    Intervention: Drug: LM-302 Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2021)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 8, 2025
Estimated Primary Completion Date March 10, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be enrolled into the study only if they meet all of the following 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenxiu Ding 021-68889618 wenxiuding@lanovamed.com
Contact: Paul Kong 021-68889618 Paulkong@lanovamed.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05161390
Other Study ID Numbers  ICMJE LM302-01-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party LaNova Medicines Limited ( LaNova Medicines Zhejiang Co., Ltd. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LaNova Medicines Zhejiang Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Li Shanghai East Hospital
Principal Investigator: Wei Shen Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Principal Investigator: Yuping Sun Shandong Province Cancer Hospital
Principal Investigator: Yanqiao Zhang Harbin Medical University
Principal Investigator: Jianping Xiong The First Affiliated Hospital of Nanchang University
Principal Investigator: Wenhui Lou Shanghai Zhongshan Hospital
PRS Account LaNova Medicines Limited
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP