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

Sponsor
LaNova Medicines Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05647512
Collaborator
(none)
380
Enrollment
2
Arms
35.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 RRMM and Other Plasma Cell Diseases
Anticipated Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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: LM-305
Administered intravenously

Drug: Dexamethasone
Administered orally

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Adverse Events and Serious Adverse Events [From signing the ICF until 28 days after EOT or accept other anti-cancer therapy]

    The safety profile of LM-305 will be assessed by monitoring the adverse events (AE)

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • LaNova Medicines Limited

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LaNova Medicines Limited
ClinicalTrials.gov Identifier:
NCT05647512
Other Study ID Numbers:
  • LM305-01-102
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dexamethasone

Study Results

No Results Posted as of Dec 12, 2022