Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

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) and Other Plasma Cell Diseases

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05647512
• Other study ID #: LM305-01-102
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 18, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: LaNova Medicines Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• LM-305
Administered intravenously
• Dexamethasone
Administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LaNova Medicines Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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)