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

November 15, 2023 updated by: LaNova Medicines Limited

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LM-305 Dose Escalation
Administered intravenously
Drug: LM-305
Administered intravenously
Experimental: LM-305 Combination Expansion
LM-305 Administered intravenously Dexamethasone Orally
Drug: Dexamethasone
Administered orally
Drug: LM-305
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity (DLT)
Time Frame: 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
Cycle 1 of each cohort. Duration of one cycle is 21 days
Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: 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
From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under plasma concentration vs time curve (AUC) for LM-305
Time Frame: Up to finished cycle 5 (each cycle is 21 days)
changes in AUC over time in participants with LM-305
Up to finished cycle 5 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LaNova Medicines Limited

Investigators

  • Principal Investigator: Depei Wu, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM305-01-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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