Drugs / IBI3003
last change 11 days ago re-read 9 days ago

IBI3003

Developed for
plasma cell myeloma · refractory plasma cell neoplasm
Investigated by
Innovent Biologics (Suzhou) Co. Ltd. · Fortvita Biologics (USA)Inc.

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 trials
Phase 1/2 NCT07336472 Sep 2026 → Jun 2027 expected plasma cell myeloma Fortvita Biologics (USA)Inc. Recruiting No outcome recorded
Phase 1/2 NCT06083207 Jul 2024 → Oct 2026 expected plasma cell myeloma Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07623798 Jun 2026 → May 2029 expected refractory plasma cell neoplasm Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-09-29 Innovent Biologics (Suzhou) Co. Ltd. Results 2026 IMS Oral Presentation: Innovent Announces Updated Phase 1 Clinical Data of Trispecific Antibody IBI3003 (GPRC5D/BCMA/CD3) in Patients with Relapsed or Refractory Multiple Myeloma innoventbio.com ↗
At the RP2D, IBI3003 demonstrated rapid, deep, and durable response signals, particularly in heavily pretreated, high-risk patients with extramedullary disease.
2026-01-27 Innovent Biologics (Suzhou) Co. Ltd. Regulatory Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).
2025-12-08 Innovent Biologics (Suzhou) Co. Ltd. Results ASH 2025 Oral Presentation: Innovent Biologics Announces Initial Results of the First-in-Human Phase 1 Study of Trispecific Antibody IBI3003 in Relapsed or Refractory Multiple Myeloma innoventbio.com ↗
IBI3003 demonstrated favorable tolerability and a manageable safety profile.

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as IBI3003 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06083207 ↗
2

NCT07336472 ↗

NCT07623798 ↗