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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06083207




Registration number
NCT06083207
Ethics application status
Date submitted
9/10/2023
Date registered
13/10/2023
Date last updated
30/08/2024

Titles & IDs
Public title
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
CIBI3003A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3003

Experimental: IBI3003 -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events (AEs)
Timepoint [1] 0 0
Up to 30 days post last dose
Secondary outcome [1] 0 0
Dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days post first dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wollongong Private Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangxi
Country [3] 0 0
China
State/province [3] 0 0
Hubei
Country [4] 0 0
China
State/province [4] 0 0
Jiangsu
Country [5] 0 0
China
State/province [5] 0 0
Jiangxi
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
China
State/province [7] 0 0
Shaxi
Country [8] 0 0
China
State/province [8] 0 0
Tianjin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06083207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Serena Dong
Address 0 0
Country 0 0
Phone 0 0
0512 69566088
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06083207