NCT04984434

Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	F182112	Eight dose cohorts: 0.01, 0.1, 0.3, 1, 3, 10, 20 and 30 μg/kg) d1 treat every weeks.

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-07-30
• Completion: 2023-12-30
• First posted: 2021-07-30
• Last updated: 2021-07-30

Locations

1 site across 1 country: China