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RecruitingNCT06682780Updated Aug 28, 2026

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

A Phase 1/2 interventional study of LM-2417 and Docetaxel in Advanced Solid Tumor, sponsored by LaNova Medicines Limited. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by LaNova Medicines Limited · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
320
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

LaNova Medicines Limited is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    LM2417 Dose Escalation(Q2W/Q3W)

    Drug: LM-2417

  • Experimental
    LM-2417 combination therapy exploratory

    Drug: LM-2417 · Drug: Docetaxel · Drug: Toripalimab/Tirelizumab · Drug: Carboplatin · Drug: Niraparib · Drug: Lenvatinib

  • Experimental
    LM-2417 combination expansion

    Drug: LM-2417 · Drug: Docetaxel · Drug: Toripalimab/Tirelizumab · Drug: Carboplatin · Drug: Niraparib · Drug: Lenvatinib

Interventions

  • DrugLM-2417

    Q2W/Q3W,Intravenous Drip

  • DrugDocetaxel

    Q3W,Intravenous Drip

  • DrugToripalimab/Tirelizumab

    Q3W,Intravenous Drip

  • DrugCarboplatin

    Q3W,Intravenous Drip

  • DrugNiraparib

    QD,Oral Administration

  • DrugLenvatinib

    QD,Oral Administration

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    Phase I/II

    Time frame: 60 weeks

  2. Incidence of dose-limitingtoxicity (DLT)

    Phase I/II

    Time frame: 60 weeks

  3. Incidence of serious adverse event (SAE)

    Phase I/II

    Time frame: 60 weeks

  4. Temperatures

    Phase I/II

    Time frame: 60 weeks

  5. Pulse in BPM(Beat per Minute)

    Phase I/II

    Time frame: 60 weeks

  6. Blood Pressure in mmHg

    Phase I/II

    Time frame: 60 weeks

  7. Weight in Kg

    Phase I/II

    Time frame: 60 weeks

  8. Height in centimeter

    Phase I/II

    Time frame: 60 weeks

  9. Laboratory tests-Blood Routine examination

    Phase I/II

    Time frame: 60 weeks

  10. Laboratory tests-Urine Routine test

    Phase I/II

    Time frame: 60 weeks

  11. Laboratory tests-Blood biochemistry

    Phase I/II

    Time frame: 60 weeks

  12. Laboratory tests- Coangulation function

    Phase I/II

    Time frame: 60 weeks

  13. Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

    Phase I/II

    Time frame: 60 weeks

  14. 12-lead electrocardiogram (ECG) in HR

    Phase I/II

    Time frame: 60 weeks

  15. 12-lead electrocardiogram (ECG) in RR

    Phase I/II

    Time frame: 60 weeks

  16. 12-lead electrocardiogram (ECG) in PR

    Phase I/II

    Time frame: 60 weeks

  17. 12-lead electrocardiogram (ECG) in QRS

    Phase I/II

    Time frame: 60 weeks

  18. 12-lead electrocardiogram (ECG) in QT

    Phase I/II

    Time frame: 60 weeks

  19. 12-lead electrocardiogram (ECG) in QTcF

    Phase I/II

    Time frame: 60 weeks

  20. ECOG(Eastern Cooperative Oncology Group) score

    Phase I/II

    Time frame: 60 weeks

  21. Overall Response Rate (ORR)

    Phase I/II

    Time frame: 76 weeks

Secondary outcomes

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

    Phase I/II

    Time frame: 112 weeks

  2. PK Parameter:Time of Maximum Observed Concentration (Tmax)

    Phase I/II

    Time frame: 112 weeks

  3. PK Parameter: Area Under the Concentration-time Curve(AUC)

    Phase I/II

    Time frame: 112 weeks

  4. PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)

    Phase I/II

    Time frame: 112 weeks

  5. PK Parameter: Steady State Minimum Concentration(Cmin,ss)

    Phase I/II

    Time frame: 112 weeks

  6. PK Parameter: Systemic Clearance at Steady State (CLss)

    Phase I/II

    Time frame: 112 weeks

  7. PK Parameter: Accumulation Ratio (Rac)

    Phase I/II

    Time frame: 112 weeks

  8. PK Parameter: Elimination Half-life (t1/2)

    Phase I/II

    Time frame: 112 weeks

  9. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Phase I/II

    Time frame: 112 weeks

  10. PK Parameter: Degree of Fluctuation (DF)

    Phase I/II

    Time frame: 112 weeks

  11. Immunogenicity of LM-2417

    Phase I/II

    Time frame: 112 weeks

  12. Biomarker correlation(NaPi2b)

    Phase I/II

    Time frame: 112 weeks

  13. Duration of Response (DOR) in Month

    Phase I/II

    Time frame: 64 weeks

  14. Disease control rate (DCR) in percentage

    Phase I/II

    Time frame: 64 weeks

  15. progression-free survival (PFS) in Month

    Phase I/II

    Time frame: 64 weeks

  16. Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month

    Phase I/II

    Time frame: 64 weeks

  17. Changes of target lesions from baseline in Millimeter

    Phase I/II

    Time frame: 64 weeks

  18. AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)

    Phase I/II

    Time frame: 64 weeks

07

Study locations

1 of 1 sites recruiting
  • FuDan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    • Xiaohua Wu, Dr · Contact
    • Hongxia Wang · Contact
    • Xiaohua Wu · Principal investigator
    • Hongxia Wang · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682780
Lead sponsor
LaNova Medicines Limited
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Sep 17, 2025
Primary completion
Dec 25, 2028 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Aug 28, 2026

Study contacts

Lingli Zhao
Contact
linglizhao@lanovamed.com
+8618901636324
Paul Kong
Contact
paulkong@lanovamed.com
+8613564682439

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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