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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-29

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IBI3003

Group Type EXPERIMENTAL

IBI3003

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Site Status SUSPENDED

Austin Hospital

Heidelberg, Victoria, Australia

Site Status SUSPENDED

St Vincent's Hospital

Melbourne, Victoria, Australia

Site Status SUSPENDED