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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LM-2417; Drug: Docetaxel; Drug: Toripalimab/Tirelizumab; Drug: Carboplatin; Drug: Niraparib; Drug: Lenvatinib

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alex Yuan; Phone Number: +8615901815211; Email: alexyuan@lanovamed.com
• Study Contact Backup: Name: Paul Kong; Phone Number: +8613564682439; Email: paulkong@lanovamed.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Hongxia Wang
      • Principal Investigator: Xiaohua Wu
      • Principal Investigator: Hongxia Wang
      • Contact: Xiaohua Wu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM2417 Dose Escalation(Q2W/Q3W)	Drug: LM-2417; Q2W/Q3W,Intravenous Drip
Experimental: LM-2417 combination therapy exploratory	Drug: LM-2417; Q2W/Q3W,Intravenous Drip; Drug: Docetaxel; Q3W,Intravenous Drip; Drug: Toripalimab/Tirelizumab; Q3W,Intravenous Drip; Drug: Carboplatin; Q3W,Intravenous Drip; Drug: Niraparib; QD,Oral Administration; Drug: Lenvatinib; QD,Oral Administration
Experimental: LM-2417 combination expansion	Drug: LM-2417; Q2W/Q3W,Intravenous Drip; Drug: Docetaxel; Q3W,Intravenous Drip; Drug: Toripalimab/Tirelizumab; Q3W,Intravenous Drip; Drug: Carboplatin; Q3W,Intravenous Drip; Drug: Niraparib; QD,Oral Administration; Drug: Lenvatinib; QD,Oral Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Phase I/II	60 weeks
Incidence of dose-limitingtoxicity (DLT)	Phase I/II	60 weeks
Incidence of serious adverse event (SAE)	Phase I/II	60 weeks
Temperatures	Phase I/II	60 weeks
Pulse in BPM(Beat per Minute)	Phase I/II	60 weeks
Blood Pressure in mmHg	Phase I/II	60 weeks
Weight in Kg	Phase I/II	60 weeks
Height in centimeter	Phase I/II	60 weeks
Laboratory tests-Blood Routine examination	Phase I/II	60 weeks
Laboratory tests-Urine Routine test	Phase I/II	60 weeks
Laboratory tests-Blood biochemistry	Phase I/II	60 weeks
Laboratory tests- Coangulation function	Phase I/II	60 weeks
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in HR	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in RR	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in PR	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in QRS	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in QT	Phase I/II	60 weeks
12-lead electrocardiogram (ECG) in QTcF	Phase I/II	60 weeks
ECOG(Eastern Cooperative Oncology Group) score	Phase I/II	60 weeks
Overall Response Rate (ORR)	Phase I/II	76 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)	Phase I/II	112 weeks
PK Parameter:Time of Maximum Observed Concentration (Tmax)	Phase I/II	112 weeks
PK Parameter: Area Under the Concentration-time Curve(AUC)	Phase I/II	112 weeks
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)	Phase I/II	112 weeks
PK Parameter: Steady State Minimum Concentration(Cmin,ss)	Phase I/II	112 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)	Phase I/II	112 weeks
PK Parameter: Accumulation Ratio (Rac)	Phase I/II	112 weeks
PK Parameter: Elimination Half-life (t1/2)	Phase I/II	112 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)	Phase I/II	112 weeks
PK Parameter: Degree of Fluctuation (DF)	Phase I/II	112 weeks
Immunogenicity of LM-2417	Phase I/II	112 weeks
Biomarker correlation(NaPi2b)	Phase I/II	112 weeks
Duration of Response (DOR) in Month	Phase I/II	64 weeks
Disease control rate (DCR) in percentage	Phase I/II	64 weeks
progression-free survival (PFS) in Month	Phase I/II	64 weeks
Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month	Phase I/II	64 weeks
Changes of target lesions from baseline in Millimeter	Phase I/II	64 weeks
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	64 weeks

Collaborators and Investigators

• Sponsor: LaNova Medicines Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): December 25, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Carboplatin; toripalimab; niraparib; lenvatinib
• Other Study ID Numbers: LM2417-01-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No