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

Phase 1

Withdrawn

• Conditions: Relapsed or Refractory Multiple Myeloma; Other Plasma Cell Diseases
• Interventions: Drug: LM-305; Drug: Dexamethasone

• Registration Number: NCT05647512
• Lead Sponsor: LaNova Medicines Limited

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)

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-12
• Study Start: 2023-01-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LM-305 Dose Escalation	LM-305	Administered intravenously
LM-305 Combination Expansion	LM-305	LM-305 Administered intravenously Dexamethasone Orally
LM-305 Combination Expansion	Dexamethasone	LM-305 Administered intravenously Dexamethasone Orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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