A First-in-human, Open-label, Multiple Center Phase 1 Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy of F182112 in Patients With Relapsed or Refractory Multiple Myeloma.

Shandong New Time Pharmaceutical Co., LTD1 site in 1 country68 target enrollmentJuly 30, 2021

ConditionsDose-Escalation Study, Relapsed or Refractory Multiple Myeloma

InterventionsF182112

DrugsF182112

Overview

Phase: Phase 1
Intervention: F182112
Conditions: Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma
Sponsor: Shandong New Time Pharmaceutical Co., LTD
Enrollment: 68
Locations: 1
Primary Endpoint: Maximum Tolerated Dose (MTD)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of F182112 when infused IV.

Detailed Description

To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of F182112 as monotherapy in patients with relapsed or refractory multiple myeloma (MM).

Registry

clinicaltrials.gov

Start Date

July 30, 2021

End Date

December 30, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong New Time Pharmaceutical Co., LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures;
•Male or female ≥ 18 years;
•Patient has a history of multiple myeloma with relapsed and refractory disease, and must:
•Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;
•Must have received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent;
•ECOG of 0-2;
•Patients must have measurable disease, including at least one of the criteria below:
•M-protein ≥ 0.5 g/dL by SPEP/immunofixation or
•≥ 200 mg/24 hours urine collection by UPEP or
•Serum free light chain (FLC) levels \> 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein;

Exclusion Criteria

•Patient has primary light chain amyloidosis or plasma cell leukemia;
•Patient has symptomatic central nervous system involvement of multiple myeloma;
•Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;
•Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);
•Patient has received ≥ 40 mg/day dexamethasone equivalent within 7 days before starting F
•Short term use of corticosteroids at doses equivalent to \> 10 mg/d of prednisone；
•Received any monoclonal antibody therapy within 30 days;
•Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
•Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;
•Live virus vaccine within 30 days prior to study entry;