A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
- 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.
- Short title
- A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2029-12-01
- First posted
- 2024-11-12
- Registry last updated
- 2026-08-28
- Primary completion date
- 2028-12-25
- Start date
- 2025-09-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- LaNova Medicines Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06682780
- ClinicalTrials.gov ID
- NCT06682780
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Incidence of adverse events (AEs)
Timeframe: 60 weeks
Phase I/II
Incidence of dose-limitingtoxicity (DLT)
Timeframe: 60 weeks
Phase I/II
Incidence of serious adverse event (SAE)
Timeframe: 60 weeks
Phase I/II
Temperatures
Timeframe: 60 weeks
Phase I/II
Pulse in BPM(Beat per Minute)
Timeframe: 60 weeks
Phase I/II
Blood Pressure in mmHg
Timeframe: 60 weeks
Phase I/II
Weight in Kg
Timeframe: 60 weeks
Phase I/II
Height in centimeter
Timeframe: 60 weeks
Phase I/II
Laboratory tests-Blood Routine examination
Timeframe: 60 weeks
Phase I/II
Laboratory tests-Urine Routine test
Timeframe: 60 weeks
Phase I/II
Laboratory tests-Blood biochemistry
Timeframe: 60 weeks
Phase I/II
Laboratory tests- Coangulation function
Timeframe: 60 weeks
Phase I/II
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in HR
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in RR
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in PR
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QRS
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QT
Timeframe: 60 weeks
Phase I/II
12-lead electrocardiogram (ECG) in QTcF
Timeframe: 60 weeks
Phase I/II
ECOG(Eastern Cooperative Oncology Group) score
Timeframe: 60 weeks
Phase I/II
Overall Response Rate (ORR)
Timeframe: 76 weeks
Phase I/II
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Timeframe: 112 weeks
Phase I/II
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Area Under the Concentration-time Curve(AUC)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Systemic Clearance at Steady State (CLss)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Accumulation Ratio (Rac)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Elimination Half-life (t1/2)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Volume of Distribution at Steady-State (Vss)
Timeframe: 112 weeks
Phase I/II
PK Parameter: Degree of Fluctuation (DF)
Timeframe: 112 weeks
Phase I/II
Immunogenicity of LM-2417
Timeframe: 112 weeks
Phase I/II
Biomarker correlation(NaPi2b)
Timeframe: 112 weeks
Phase I/II
Duration of Response (DOR) in Month
Timeframe: 64 weeks
Phase I/II
Disease control rate (DCR) in percentage
Timeframe: 64 weeks
Phase I/II
progression-free survival (PFS) in Month
Timeframe: 64 weeks
Phase I/II
Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month
Timeframe: 64 weeks
Phase I/II
Changes of target lesions from baseline in Millimeter
Timeframe: 64 weeks
Phase I/II
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)
Timeframe: 64 weeks
Phase I/II
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged 18-80 years old (including boundary values) , male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.
- Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
- At least one evaluable lesion.
- Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.
- 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.
- 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.
- Previously received with same target therapy.
- Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.
- Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- Poorly controlled tumor-related pain.
- Subjects with symptomatic/active central nervous system (CNS)metastases.
- Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Subjects with known hypersensitivity to antibody therapy;
- 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.
- Previous or current known autoimmune disease.
- Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;
- Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
- Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417.
- Subject who have history of severe cardiovascular disease.
- Subjects who have uncontrolled or severe illness.
- HIV infection, active HBV or HCV infection.
- Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
- Subject who is judged as not eligible to participate in this study by the investigator.
- FuDan University Shanghai Cancer CenterShanghai, ChinaRecruiting