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RECRUITING
NCT06083207
PHASE1/PHASE2

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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 23\~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.

Official title: A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2024-07-29

Completion Date

2027-10-31

Last Updated

2024-12-13

Healthy Volunteers

No

Interventions

DRUG

IBI3003

Subjects will receive IBI3003 on Day 1 in a 28-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and pharmacokinetic(PK) data), until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.

Locations (13)

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Austin Hospital

Heidelberg, Victoria, Australia

St Vincent's Hospital

Melbourne, Victoria, Australia

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The first Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Tongji Medical College of HUST Tongji Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of XI'AN Jiaotong University

Xian, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China