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IBI3003

Phase 1

Multiple Myeloma | Small molecule | Oncology |BrainsWay Ltd.|Last Updated: Feb 25, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment360

FDA Designations

No designations recorded

Clinical trial landscape

IBI3003 · 1 trial · 1 indication

Phase 1 1
NCT07336472A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
NOT YET_RECRUITING360 Analytics
PHASE1NOT YET_RECRUITING
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Dose limiting toxicities (DLTs)
Up to 28 days post first dose

To evaluate the safety and tolerability of IBI3003

ORR
up to 24 months

To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003
up to 24 months

Secondary Endpoints

Incidence and characterization of anti-drug antibody (ADA).
up to 24 months
Preliminary efficacy including objective response rate (ORR)
up to 24 months
To evaluate minimal residual disease (MRD) negativity rates. MRD negativity rate.
up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IBI3003EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
IBI3003DRUGParticipants 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria Participants in Parts 1 \& 2 must satisfy all of the following criteria to be enrolled in the study: 1. Age ≥18 years. 2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥1...

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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about IBI3003

What is IBI3003 used for?

IBI3003 is an investigational small molecule being developed for the treatment of multiple myeloma. It is currently in Phase 1 clinical development for patients with relapsed or refractory multiple myeloma. The drug is being studied in a single-arm, open-label trial to evaluate its safety and efficacy in this patient population.

Who is developing IBI3003?

IBI3003 is being developed by BrainsWay Ltd., a biopharmaceutical company traded on the stock exchange under the ticker symbol BWAY. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with relapsed or refractory multiple myeloma.

What phase is IBI3003 in?

IBI3003 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of IBI3003 in patients with relapsed or refractory multiple myeloma.

What clinical trials is IBI3003 in?

IBI3003 is being evaluated in a Phase 1 clinical trial with the identifier NCT07336472. This study is titled 'A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma' and is currently not yet recruiting participants. The trial plans to enroll approximately 360 patients aged 18 years and older.

Is IBI3003 a targeted therapy?

IBI3003 is a small molecule being developed for multiple myeloma. The clinical trial for IBI3003 includes biomarker selection, indicating that the study may involve patients whose tumors express specific biomarkers. However, the specific molecular target of IBI3003 has not been disclosed in the available information.