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Izalontamab brengitecan

Phase 3

Lung Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 26, 2026

Izalontamab brengitecan development status

Highest phase Phase 3 (NCT07680790)
Phase scored for BMYPhase 1
Registered trials 23 across 2 sponsors since Mar 2024

Izalontamab brengitecan target and mechanism

Target class-Mab (Antibody)
ModalityMonoclonal antibody

Also known as BMS-986507, Iza-bren, BL-B01D1

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials5
Total Enrollment2,836

FDA Designations

No designations recorded

Izalontamab brengitecan clinical trials

Izalontamab brengitecan · 5 trials · 5 indications

Phase 3 1Phase 2 3Phase 1 1
NCT07680790Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)Non-Small Cell Lung Cancer
RECRUITING850 Analytics
PHASE3RECRUITING
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Up to approximately 3 years
Recommended Phase 3 Dose (RP3D) of BMS-986507
Approximately 3 months after the first dose

Phase 2

Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Up to 3 years

Phase 3

Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
Up to 5 years

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

Phase 3: Overall Survival (OS)
Up to 5 years
Progression-Free Survival (PFS)
Approximately 22 months from first participant randomization in Phase 3

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

Number of participants with adverse events (AEs)
Up to 3 years
Number of participants with serious adverse events (SAEs)
Up to 3 years
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
Up to 3 years
Number of participants with AEs leading to discontinuation
Up to 3 years
Number of participants with AEs leading to death
Up to 3 years
Number of DLTs that occur during the DLT evaluation period
Up to 3 weeks

Secondary Endpoints

Overall Survival (OS)
Up to approximately 5 years
PFS assessed by the investigator as per RECIST v1.1
Up to approximately 3 years
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Up to approximately 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm CACTIVE_COMPARATOR -
Arm DEXPERIMENTAL -
Arm EACTIVE_COMPARATOR -
Arm A1EXPERIMENTAL -
Arm A2EXPERIMENTAL -
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -

Interventions

NameTypeDescription
Iza-brenDRUGSpecified dose on specified days
OsimertinibDRUGSpecified dose on days
PemetrexedDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
CapecitabineDRUGSpecified dose on specified days
BMS-986507DRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites204

Inclusion Criteria: * Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatmen...

Countries:United StatesArgentinaAustraliaBrazilCanadaChinaFranceGermanyIndiaItalyJapanSouth KoreaSpainTaiwanThailandTurkey (Türkiye)BelgiumChileColombiaGreeceMexicoNetherlandsNorwayPolandRomaniaSingaporeSwitzerlandUnited KingdomAustriaCzechiaIrelandIsraelSwedenPortugalSouth AfricaUnited Arab Emirates
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Competitive Landscape -Lung Cancer 400 trials

Top 20 of 75 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Telisotuzumab Adizutecan, ABBV-706, ABBV-324
Merck & Co., Inc.MRK17PHASE3Pembrolizumab, Olaparib, Pembrolizumab Berahyaluronidase alfa, Ifinatamab Deruxtecan, Patritumab Deruxtecan
Gilead Sciences, Inc.GILD6PHASE3Sacituzumab govitecan, Domvanalimab, Quemliclustat, Zimberelimab, Etrumadenant
Amgen Inc.AMGN16PHASE3Tarlatamab, ABP 234
AstraZeneca PLCAZN38PHASE3Durvalumab, Tremelimumab, Volrustomig, Dato-DXd, Osimertinib
Bristol-Myers Squibb CompanyBMY17PHASE3Adagrasib, BMS-986489, Nivolumab, Ipilimumab, Navlimetostat
BioNTech SE Sponsored ADRBNTX6PHASE3Pumitamig, BNT324
Eli Lilly and CompanyLLY4PHASE3Ramucirumab, LY4175408
Pfizer Inc.PFE16PHASE3PF-08634404, PF-07104091, Prifetrastat, Palbociclib, PF-07220060
ArriVent BioPharma, Inc.AVBP6PHASE3Firmonertinib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-B2033
Revolution Medicines, Inc.RVMD3PHASE3Daraxonrasib, Zoldonrasib, Elironrasib
Zai Lab Ltd. Sponsored ADRZLAB4PHASE3ZL-1310
Summit Therapeutics IncSMMT1PHASE3Ivonescimab
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Lurbinectedin
Immutep Ltd Sponsored ADRIMMP2PHASE3eftilagimod alfa (efti / IMP321), IMP321
GSK plc Sponsored ADRGSK2PHASE3Risvutatug rezetecan
Regeneron Pharmaceuticals, Inc.REGN6PHASE2Cemiplimab, Fianlimab, Ubamatamab, Marlotamig
ImmunityBio IncIBRX2PHASE3Nogapendekin alfa inbakicept
Novartis AG Sponsored ADRNVS9PHASE2Opnurasib, Spartalizumab, Lutetium Lu 177 Dotatate, Gallium 68 Dotatate, TNO155
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Recent Changes (Last 90 Days)

LOWOct 26, 2026NCT07680790lastUpdatePostDate: changed
LOWOct 26, 2026NCT07680790lastUpdatePostDate: changed
LOWOct 9, 2026NCT07100080lastUpdatePostDate: changed
LOWOct 9, 2026NCT07100080lastUpdatePostDate: changed
LOWOct 8, 2026NCT07680790Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 8, 2026NCT07680790Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 23, 2026NCT06618287lastUpdatePostDate: changed
LOWSep 23, 2026NCT06618287lastUpdatePostDate: changed
LOWSep 22, 2026NCT07100080lastUpdatePostDate: changed
LOWSep 22, 2026NCT07100080lastUpdatePostDate: changed
LOWSep 15, 2026NCT06618287lastUpdatePostDate: changed
LOWSep 15, 2026NCT06618287lastUpdatePostDate: changed
LOWSep 15, 2026NCT06618287lastUpdatePostDate: changed
LOWAug 25, 2026NCT07100080lastUpdatePostDate: changed
LOWAug 25, 2026NCT07100080lastUpdatePostDate: changed
LOWAug 24, 2026NCT07680790lastUpdatePostDate: changed
LOWAug 24, 2026NCT07680790lastUpdatePostDate: changed
LOWAug 19, 2026NCT06618287lastUpdatePostDate: changed
LOWAug 19, 2026NCT06618287lastUpdatePostDate: changed
LOWAug 19, 2026NCT06618287lastUpdatePostDate: changed

Frequently asked questions about Izalontamab brengitecan

What is izalontamab brengitecan used for?

Izalontamab brengitecan is an investigational therapy being studied in adults with advanced solid tumors, including lung cancer and breast cancer. It is not yet approved for any indication and remains in clinical development. Bristol-Myers Squibb is evaluating it both as a single agent and in combinations.

Who makes izalontamab brengitecan?

Izalontamab brengitecan is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating the agent in advanced solid tumors.

What phase is izalontamab brengitecan in?

Izalontamab brengitecan is in Phase 1 clinical development. The only registered trial of the agent is a Phase 1 study that is currently recruiting participants. It has not completed any trials and is not approved by the FDA for any use.

What clinical trials is izalontamab brengitecan in?

Izalontamab brengitecan is being studied in the Phase 1 trial NCT06618287, titled a study to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors. The trial is recruiting and plans to enroll 416 participants across the United States, Australia, Canada, Chile, France, Italy, the Netherlands, Spain, Taiwan, and the United Kingdom.

Is izalontamab brengitecan the same as BMS-986507?

Yes, izalontamab brengitecan is also known as BMS-986507. BMS-986507 is the Bristol-Myers Squibb development code for the same investigational agent. Both names refer to the identical molecule being studied in the Phase 1 trial NCT06618287 in advanced solid tumors.

What is izalontamab brengitecan used for in lung cancer?

Izalontamab brengitecan is being evaluated in a Phase 1 trial that includes patients with lung cancer among other advanced solid tumors. The study is testing the agent in combinations and includes biomarker-selected participants. It is investigational and has not been approved for lung cancer or any other indication.