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

Primary Purpose

Multiple Myeloma

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
IBI3003
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study: Age ≥18 years. For Part 1, age ≥18 years and ≤75 years. 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 Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Life expectancy ≥3 months. 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: Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 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. 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. History of primary immunodeficiency. 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.

Sites / Locations

  • Wollongong Private Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBI3003

Arm Description

Outcomes

Primary Outcome Measures

Adverse events (AEs)
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose

Secondary Outcome Measures

Dose limiting toxicities (DLTs)
To evaluate the safety and tolerability of IBI3003

Full Information

First Posted
October 9, 2023
Last Updated
October 18, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06083207
Brief Title
A Study of IBI3003 in Subjects With Relapsed or Refractory 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI3003
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IBI3003
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse events (AEs)
Description
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose
Time Frame
Up to 30 days post last dose
Secondary Outcome Measure Information:
Title
Dose limiting toxicities (DLTs)
Description
To evaluate the safety and tolerability of IBI3003
Time Frame
Up to 28 days post first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study: Age ≥18 years. For Part 1, age ≥18 years and ≤75 years. 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 Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Life expectancy ≥3 months. 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: Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 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. 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. History of primary immunodeficiency. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serena Dong
Phone
0512 69566088
Email
suhua.dong@innoventbio.com
Facility Information:
Facility Name
Wollongong Private Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Presgrave
Phone
+612 42534009
Email
Peter.presgrave@health.nsw.gov.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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