A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Administered intravenously
Administered orally
Dose limiting toxicity (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period
Time frame: Cycle 1 of each cohort. Duration of one cycle is 21 days
Adverse Events (AE) and Serious Adverse Events (SAE)
The safety profile of LM-305 will be assessed by monitoring the adverse events
Time frame: From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy
Area under plasma concentration vs time curve (AUC) for LM-305
changes in AUC over time in participants with LM-305
Time frame: Up to finished cycle 5 (each cycle is 21 days)
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