A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFortvita Biologics (USA)Inc.
About this trial
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 54\~360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or corrected serum calcium >2.75 mmol/L (>11 mg/dL) Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 μmol/L (>2 mg/dL) Anemia: hemoglobin value of >2 g/dL below the lower limit of normal, or a hemoglobin value <10 g/dL Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
Relapsed or refractory measurable multiple myeloma (R/R MM) following prior treatment with ≥3 lines of systemic anti-myeloma therapy that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy, and with limited or no therapeutic options that are likely to offer a favorable risk/benefit profile; participants must be relapsed or refractory to their last anti-myeloma regimen.
Disqualifiers
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Active amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering multiple myeloma (MM) as defined by the IMWG criteria.
Spinal cord compression that results in limited self-care at present or within 6 months prior to informed consent, or that is expected to cause such limitations during Study participation.
History of primary immunodeficiency.
Trial design
Design model
Single group
Treatments tested in this trial
IBI3003
DrugParticipants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.
Treatment groups
360 Participants
are divided into 1 treatment groupGroup A: IBI3003Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
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 dose2
Dose limiting toxicities (DLTs)
To evaluate the safety and tolerability of IBI3003
Time frame
Up to 28 days post first dose3
ORR
To evaluate the preliminary efficacy of IBI3003 in the specified participant population.
Time frame
up to 24 months4
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003
Time frame
up to 24 monthsSecondary outcomes
1
Incidence and characterization of anti-drug antibody (ADA).
To evaluate the immunogenicity of IBI3003
Time frame
up to 24 months2
Preliminary efficacy including objective response rate (ORR)
objective response rate. To evaluate the preliminary efficacy of IBI3003 in the specified participant population.
Time frame
up to 24 months3
To evaluate minimal residual disease (MRD) negativity rates. MRD negativity rate.
To evaluate minimal residual disease (MRD) negativity rates.
Time frame
up to 24 months4
efficacy estimates sCRR
stringent complete response rate. To evaluate other efficacy estimates of IBI3003 in the participant population.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov