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According to sponsor strategy
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-305 Dose Escalation | Experimental | Administered intravenously |
|
| LM-305 Combination Expansion | Experimental | LM-305 Administered intravenously Dexamethasone Orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-305 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period | 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 | From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration vs time curve (AUC) for LM-305 | changes in AUC over time in participants with LM-305 | Up to finished cycle 5 (each cycle is 21 days) |
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Inclusion Criteria:
Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study, if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Depei Wu | The First Affiliated Hospital of Soochow University | Principal Investigator |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | Administered orally |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |