NCT07312188

A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Detailed description

The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers. Primary objective: The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma. Secondary objective: The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate \[CRR\], progression - free survival \[PFS\], overall survival \[OS\], duration of response \[DOR\], time to response \[TTR\], time to progression \[TTP\], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	F182112+P	F182112 + P
DRUG	F182112+CD38	F182112+CD38

Timeline

• Start date: 2025-07-02
• Primary completion: 2028-05-20
• Completion: 2028-05-20
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China