NCT07336472

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase I/II, Multicenter, Open-label Study of IBI3003 in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Fortvita Biologics (USA)Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 54\~360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	IBI3003	Participants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2028-09-30
• First posted: 2026-01-13
• Last updated: 2026-02-25

Regulatory

• FDA-regulated drug study