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NCT06682780 | NOT YET RECRUITING | Advanced Solid Tumor

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
Sponsor:

LaNova Medicines Limited

Brief Summary:

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

LM-2417

Docetaxel

Toripalimab/Tirelizumab

Carboplatin

Niraparib

Lenvatinib

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 320 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors
Actual Study Start Date : 2025-06-05
Estimated Primary Completion Date : 2027-12-01
Estimated Study Completion Date : 2029-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • 2. Aged 18-80 years old (including boundary values) , male or female.
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • 4. Life expectancy ≥ 3 months.
  • 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.
  • 6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
  • 7. At least one evaluable lesion.
  • 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.
  • 9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.
  • 10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.
  • Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort：Subjects tested positive for biomarkers.
Exclusion Criteria
  • 1. Previously received with same target therapy.
  • 2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
  • 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
  • 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • 5. Poorly controlled tumor-related pain.
  • 6. Subjects with symptomatic/active central nervous system (CNS)metastases.
  • 7. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 8. Subjects with known hypersensitivity to antibody therapy;
  • 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417.
  • 10. Previous or current known autoimmune disease.
  • 11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
  • 12. Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;
  • 13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
  • 14. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417.
  • 15. Subject who have history of severe cardiovascular disease.
  • 16. Subjects who have uncontrolled or severe illness.
  • 17. HIV infection, active HBV or HCV infection.
  • 18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
  • 19. Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • 20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
  • 21. Subject who is judged as not eligible to participate in this study by the investigator.
A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Location Details

NCT06682780

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Shanghai

FuDan University Shanghai Cancer Center

Shanghai, Shanghai, China,