A Study of LM-24C5 For Advanced Solid Tumors

NCT06187402 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LM24C5-01-101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 6

Brief Summary

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (14)

• Incidence of adverse events (AEs)

  Phase 1

  60 weeks

• Incidence of dose-limiting toxicity (DLT)

  Phase 1

  60 weeks

• Incidence of serious adverse event (SAE)

  Phase 1

  60 weeks

• Ear Temperature

  Phase 1

  60 weeks

• Pulse in BPM(Beat per Minute)

  Phase 1

  60 weeks

• Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)

  Phase 1

  60 weeks

• Number of participants with abnormal Hematology test results

  Phase 1

  60 weeks

• Number of participants with abnormal Urinalysis test results

  Phase 1

  60 weeks

• Number of participants with abnormal Blood Biochemistry test results

  Phase 1

  60 weeks

• Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).

  Phase 1

  60 weeks

• Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

  Phase 1

  60 weeks

• 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.

  Phase 1

  60 weeks

• ECOG(Eastern Cooperative Oncology Group) score

  Phase 1

  60 weeks

• Overall Response Rate (ORR)

  Phase 2

  36 weeks

Secondary Outcomes (26)

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

  96 weeks

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

  96 weeks

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

  96 weeks

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

  96 weeks

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

  96 weeks

Other Outcomes (1)

• Relationship between the biomarkers and the anti-tumor activity

  96 weeks

Study Arms (2)

LM-24C5 Dose Escalation

EXPERIMENTAL

Drug: LM-24C5

LM-24C5 Dose Expansion

EXPERIMENTAL

Drug: LM-24C5

Interventions

LM-24C5 DRUG

Administered intravenously

LM-24C5 Dose Escalation; LM-24C5 Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures.
• Aged ≥18 years old when sign the ICF, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
• Life expectancy ≥ 3 months.
• Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
• Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.
• At least one measurable lesion according to RECIST v1.1.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if:

• Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
• Any prior treatments towards the investigational target.
• Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.
• Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.
• Subjects with uncontrolled pain.
• Subjects with known central nervous system (CNS) or meningeal metastasis.
• Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.
• Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C5.
• Subjects with the known history of autoimmune disease.
• Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
• Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.
• Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C5.
• Subjects who have severe cardiovascular disease.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (6)

University of Southern California (USC) - Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

NOT YET RECRUITING

Ocala Oncology

Ocala, Florida, 34474, United States

RECRUITING

Indiana University Melvan and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

NOT YET RECRUITING

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Study Officials

• Terry Pang

  LaNova

  STUDY DIRECTOR

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 2, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)