{"entity":{"id":"ifinatamab-deruxtecan","kind":"drug","name":"Ifinatamab deruxtecan","aka":[],"tldr":"Ifinatamab deruxtecan is a B7-H3 ADC showing some of the best response rates ever seen in relapsed small-cell lung cancer.","summary":"Ifinatamab deruxtecan is an anti-B7-H3 IgG1 antibody carrying the topoisomerase I inhibitor DXd at a drug-to-antibody ratio of about 8 through a cleavable GGFG linker; B7-H3 is present on most small-cell lung cancers and the permeable payload kills neighbouring cells too. Daiichi Sankyo and Merck are developing it for extensive-stage SCLC after platinum, where the phase 2 IDeate-Lung01 trial reported an objective response rate around 55 percent at the selected 12 mg/kg every-3-weeks dose, among the best seen in relapsed SCLC. The phase 3 IDeate-Lung02 trial versus topotecan is ongoing, and the FDA granted Breakthrough Therapy designation in 2024. Nausea, anaemia, decreased appetite and neutropenia are common, and interstitial lung disease is monitored. It is also being studied in prostate and oesophageal cancer, and offers a lung cancer with few new options a genuinely new mechanism.","status":"phase-3","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov: trials of Ifinatamab deruxtecan","url":"https://clinicaltrials.gov/search?intr=I-DXd"}],"tags":[],"related":[],"cancers":["sclc","prostate","extensive-stage-sclc"],"sections":[],"technologies":["adc"],"targets":["b7h3"],"drugs":[],"companies":["daiichi-sankyo","merck"],"institutions":[],"pathways":[],"terms":["ggfg"],"trials":["nct06925737","nct06780137","nct05280470","nct04471727","nct06362252","nct07227597","nct04145622","nct06330064","nct07630974","nct06863272","nct06644781","nct06780085"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"I-DXd, DS-7300","modality":"ADC","payload":"DXd, DAR ~8","linker":"GGFG cleavable","mechanism":"Anti-B7-H3 IgG1 with DXd.","approvals":[],"mechanismSteps":["Antibody binds B7-H3 on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","DXd is released inside the cell","Topoisomerase-I is trapped on DNA; replication forks collapse into double-strand breaks","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"12 mg/kg every 3 weeks (IDeate-Lung01 selected dose)","monitoring":"ILD, blood counts, infusion reactions","source":"https://clinicaltrials.gov/study/NCT05280470"},"toxicity":[{"event":"Nausea"},{"event":"Anaemia"},{"event":"Decreased appetite"},{"event":"Neutropenia"},{"event":"ILD/pneumonitis"}],"access":[{"country":"US","reimbursement":"Investigational (phase 3 IDeate-Lung02)","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2024-08","type":"designation","region":"US","note":"Breakthrough Therapy designation, extensive-stage SCLC after platinum","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/ifinatamab-deruxtecan/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate-nepc","kind":"cancer","name":"Neuroendocrine and small-cell prostate cancer","route":"/cancers/prostate-nepc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"b7h3","kind":"target","name":"B7-H3","route":"/targets/b7h3/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"term":[{"id":"dxd","kind":"term","name":"DXd","route":"/terms/dxd/"},{"id":"sclc-molecular-subtypes","kind":"term","name":"Small-cell lung cancer transcription-factor subtypes (SCLC-A, SCLC-N, SCLC-P, SCLC-I) and SLFN11","route":"/terms/sclc-molecular-subtypes/"},{"id":"ggfg","kind":"term","name":"Tetrapeptide GGFG (maleimide-GGFG-aminomethyl)","route":"/terms/ggfg/"},{"id":"topoisomerase-i-payloads","kind":"term","name":"Topoisomerase-I inhibitor payloads","route":"/terms/topoisomerase-i-payloads/"}],"trial":[{"id":"nct07227597","kind":"trial","name":"A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","route":"/trials/nct07227597/"},{"id":"nct06925737","kind":"trial","name":"A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","route":"/trials/nct06925737/"},{"id":"nct06863272","kind":"trial","name":"A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)","route":"/trials/nct06863272/"},{"id":"nct04471727","kind":"trial","name":"A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)","route":"/trials/nct04471727/"},{"id":"nct06362252","kind":"trial","name":"A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-","route":"/trials/nct06362252/"},{"id":"nct07630974","kind":"trial","name":"A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)","route":"/trials/nct07630974/"},{"id":"nct06644781","kind":"trial","name":"A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)","route":"/trials/nct06644781/"},{"id":"nct06780085","kind":"trial","name":"A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)","route":"/trials/nct06780085/"},{"id":"nct06330064","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)","route":"/trials/nct06330064/"},{"id":"nct06780137","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensiv","route":"/trials/nct06780137/"},{"id":"ideate-lung02","kind":"trial","name":"IDeate-Lung02","route":"/trials/ideate-lung02/"},{"id":"nct05280470","kind":"trial","name":"Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","route":"/trials/nct05280470/"},{"id":"nct04165070","kind":"trial","name":"KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)","route":"/trials/nct04165070/"},{"id":"nct04145622","kind":"trial","name":"Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors","route":"/trials/nct04145622/"}],"pairing":[{"id":"tarlatamab-vs-idxd-sequence","kind":"pairing","name":"Sequencing DLL3 engager and B7-H3 ADC in relapsed SCLC","route":"/pairings/tarlatamab-vs-idxd-sequence/"}],"pathway":[{"id":"lineage-plasticity-neuroendocrine","kind":"pathway","name":"Lineage plasticity & neuroendocrine transformation","route":"/pathways/lineage-plasticity-neuroendocrine/"},{"id":"sclc-signalling","kind":"pathway","name":"Small cell lung cancer (KEGG map)","route":"/pathways/sclc-signalling/"}],"biomarker":[{"id":"b7-h3-expression","kind":"biomarker","name":"B7-H3 (CD276) expression","route":"/biomarkers/b7-h3-expression/"}]}}