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

NCT06682780 | Recruiting Phase 1

• 1 other identifier: LM2417-01-103
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (18)

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

  112 weeks

• PK Parameter:Time of Maximum Observed Concentration (Tmax)

  112 weeks

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

  112 weeks

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

  112 weeks

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

  112 weeks

Study Arms (3)

LM2417 Dose Escalation(Q2W/Q3W)

EXPERIMENTAL

Drug: LM-2417

LM-2417 combination therapy exploratory

EXPERIMENTAL

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

LM-2417 combination expansion

EXPERIMENTAL

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

Interventions

LM-2417 DRUG

Q2W/Q3W,Intravenous Drip

LM-2417 combination expansion; LM-2417 combination therapy exploratory; LM2417 Dose Escalation(Q2W/Q3W)

Docetaxel DRUG

Q3W,Intravenous Drip

LM-2417 combination expansion; LM-2417 combination therapy exploratory

Toripalimab/Tirelizumab DRUG

Q3W,Intravenous Drip

LM-2417 combination expansion; LM-2417 combination therapy exploratory

Carboplatin DRUG

Q3W,Intravenous Drip

LM-2417 combination expansion; LM-2417 combination therapy exploratory

Niraparib DRUG

QD,Oral Administration

LM-2417 combination expansion; LM-2417 combination therapy exploratory

Lenvatinib DRUG

QD,Oral Administration

LM-2417 combination expansion; LM-2417 combination therapy exploratory

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (1)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; toripalimab; Carboplatin; niraparib; lenvatinib

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Paul Kong

CONTACT

+8613564682439; paulkong@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 25, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)