A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
NCT07336472 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-02-25
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
Interventions
- 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.
Sponsors & Collaborators
-
Fortvita Biologics (USA)Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-09-30
- FDA Drug
- Yes
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