A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors
LaNova Medicines Limited
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Aged ≥18 years old when sign the ICF, male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have p…
Interventions
- DrugLM-24C5
Administered intravenously
Locations (6)
- University of Southern California (USC) - Norris Comprehensive Cancer CenterLos Angeles, California
- Ocala OncologyOcala, Florida
- Indiana University Melvan and Bren Simon Cancer CenterIndianapolis, Indiana
- The Christ HospitalCincinnati, Ohio
- Mary Crowley Cancer Research CenterDallas, Texas
- Virginia Cancer Specialists, P.C.Fairfax, Virginia