Other Plasma Cell Diseases, Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Detailed description
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)
Interventions
DRUGLM-305
Administered intravenously
DRUGDexamethasone
Administered orally
Sponsors
LaNova Medicines Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be enrolled into the study only if they meet all of the following 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 procedure. 2. Aged ≥18 years old when sign the ICF, male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。 4. Life expectancy ≥ 6 months. 5. Subjects must show appropriate organ and marrow function in laboratory examinations
Exclusion criteria
Subjects will be excluded from the study, if they meet any of the following criteria: 1. A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing 2. Subjects who have severe cardiovascular disease。 3. Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP. 4. Child-bearing potential female who have positive results in pregnancy test or are lactating. 5. Subject who is judged as not eligible to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | Cycle 1 of each cohort. Duration of one cycle is 21 days | DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period |
| Adverse Events (AE) and Serious Adverse Events (SAE) | From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy | The safety profile of LM-305 will be assessed by monitoring the adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration vs time curve (AUC) for LM-305 | Up to finished cycle 5 (each cycle is 21 days) | changes in AUC over time in participants with LM-305 |
Outcome results
None listed