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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: IBI3003

• Registration Number: NCT06083207
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Study Start: 2024-07-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:

  1. Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
  2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  4. Life expectancy ≥3 months.
  5. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Exclusion Criteria

1. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
2. Have amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering MM as defined by the International Myeloma Working Group(IMWG) criteria.
3. Spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future.
4. History of primary immunodeficiency.
5. Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI3003	IBI3003	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 30 days post last dose	Number of patients who Experienced related AEs from the first dose until 30 days after the last dose

Secondary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLTs)	Up to 28 days post first dose	To evaluate the safety and tolerability of IBI3003

Trial Locations

Locations (13)

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Wollongong Private Hospital; 🇦🇺 Wollongong, New South Wales, Australia

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, 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, China

The First Affiliated Hospital of XI'AN Jiaotong University; 🇨🇳 Xian, Shanxi, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China