Investigational Drug
Ifinatamab deruxtecan (I-DXd; DS-7300; MK-2400) is an investigational antibody–drug conjugate being studied for several solid tumors. The most substantial published efficacy results are in previously treated extensive-stage small-cell lung cancer (ES-SCLC). A phase 3 trial is comparing it with physician’s-choice treatment in relapsed SCLC; the results below are from earlier-phase studies, not that comparison. (pubmed.ncbi.nlm.nih.gov)
The antibody targets B7-H3 (CD276), a protein expressed on many solid tumors. A cleavable linker attaches it to DXd, a topoisomerase I inhibitor intended to damage DNA after delivery to tumor cells. (sciencedirect.com)
In the phase 2 IDeate-Lung01 trial, 48.2% of 137 patients receiving 12 mg/kg had a confirmed objective response. Median response duration was 5.3 months, and median progression-free survival was 4.9 months. In a separate phase 1/2 dose-escalation study across advanced solid tumors, 24 of 70 evaluable patients (34%) had a confirmed response; that study included multiple tumor types and doses. Neither result establishes a survival benefit over existing treatment. (pubmed.ncbi.nlm.nih.gov)
In IDeate-Lung01, the most common treatment-related adverse events at 12 mg/kg were nausea (43.1%), anemia (34.3%), and neutropenia (34.3%). Adjudicated treatment-related interstitial lung disease (ILD)/pneumonitis occurred in 12.4%, including grade 3 or worse cases in 4.4%. In the separate dose-escalation study, investigators attributed one death to treatment-related ILD. (ascopubs.org)
Last updated: Sep 2026
Found 13 active trials using this drug:
TrialFetch AI summary: This single-arm study enrolls patients with measurable, unresectable locally advanced or metastatic esophageal squamous cell carcinoma that has progressed after one or two prior systemic therapies for advanced disease. Participants receive ifinatamab deruxtecan, an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor, every 3 weeks until progression or discontinuation.
ClinicalTrials.gov ID: NCT07405151
TrialFetch AI summary: For patients with extensive-stage SCLC, this study evaluates first-line induction and/or maintenance regimens combining gocatamig, an investigational DLL3×CD3 T-cell engager, with ifinatamab deruxtecan, an investigational B7-H3-directed antibody–drug conjugate carrying a topoisomerase I inhibitor. Eligible patients are either untreated or have no progression after platinum–etoposide plus PD-1/PD-L1 therapy; regimens include atezolizumab maintenance and a carboplatin–etoposide–atezolizumab comparator.
ClinicalTrials.gov ID: NCT07227597
TrialFetch AI summary: Adults with previously untreated, locally advanced unresectable or metastatic esophageal squamous cell carcinoma and ECOG performance status 0–1 receive pembrolizumab plus an investigational antibody–drug conjugate, with or without chemotherapy, or pembrolizumab plus mFOLFOX6. The investigational agents are ifinatamab deruxtecan (B7-H3–targeted) and sacituzumab tirumotecan (TROP2-targeted), both of which deliver topoisomerase I inhibitors.
ClinicalTrials.gov ID: NCT06780111
TrialFetch AI summary: This study enrolls patients with metastatic castration-resistant prostate adenocarcinoma progressing despite androgen deprivation after one or two androgen receptor pathway inhibitors, with no prior taxane chemotherapy for mCRPC. Treatments are docetaxel, ifinatamab deruxtecan (a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor), or ifinatamab deruxtecan combined with opevesostat (a CYP11A1 inhibitor), abiraterone, or enzalutamide.
ClinicalTrials.gov ID: NCT06863272
TrialFetch AI summary: Adults with stage IV squamous NSCLC that has progressed after anti-PD-(L)1 therapy and platinum-based chemotherapy are randomized to raludotatug deruxtecan (a cadherin-6–targeted ADC), ifinatamab deruxtecan (a B7-H3–targeted ADC), or docetaxel. Both ADCs deliver a topoisomerase I inhibitor payload.
ClinicalTrials.gov ID: NCT06780098
TrialFetch AI summary: This trial enrolls patients with mCRPC progressing despite androgen deprivation or orchiectomy and one or two prior androgen receptor pathway inhibitors, without prior taxane chemotherapy for mCRPC. Patients receive either ifinatamab deruxtecan, an investigational B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, or docetaxel plus prednisone.
ClinicalTrials.gov ID: NCT06925737
TrialFetch AI summary: Adults with stage IV nonsquamous NSCLC progressing after anti-PD-(L)1 therapy and platinum chemotherapy are randomized to docetaxel or one of two antibody–drug conjugates: raludotatug deruxtecan (CDH6-targeted) or ifinatamab deruxtecan (B7-H3-targeted), both delivering a topoisomerase I inhibitor. Patients must have ECOG 0–1 and no indication for first-line EGFR-, ALK-, or ROS1-directed therapy.
ClinicalTrials.gov ID: NCT06780085
TrialFetch AI summary: Adults with unresectable locally advanced or metastatic ESCC who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor are randomized to ifinatamab deruxtecan or investigator’s choice of docetaxel, paclitaxel, or irinotecan. Ifinatamab deruxtecan is an investigational B7-H3–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT06644781
TrialFetch AI summary: For patients with stage IV small cell lung cancer that has relapsed or progressed after at least one platinum-containing regimen, this study evaluates gocatamig (MK-6070), a DLL3/CD3-targeting T-cell engager, and ifinatamab deruxtecan, a B7-H3–targeting antibody–drug conjugate carrying a topoisomerase I inhibitor, alone or together. Another arm evaluates gocatamig plus the PD-L1 inhibitor durvalumab.
ClinicalTrials.gov ID: NCT06780137
TrialFetch AI summary: Adults with extensive-stage small-cell lung cancer and ECOG performance status 0–1 receive ifinatamab deruxtecan plus atezolizumab either as maintenance after responding to or remaining stable on first-line carboplatin, etoposide, and atezolizumab, or with carboplatin as initial treatment followed by maintenance. Ifinatamab deruxtecan is an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT06362252
TrialFetch AI summary: Adults with measurable relapsed extensive-stage SCLC after one platinum-based regimen and ECOG performance status 0–1 are randomized to ifinatamab deruxtecan or physician’s choice of topotecan, lurbinectedin, or amrubicin. Ifinatamab deruxtecan is an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT06203210
TrialFetch AI summary: Adults with previously treated, progressive recurrent or metastatic solid tumors across 13 cohorts receive intravenous ifinatamab deruxtecan, generally every 3 weeks. This investigational antibody–drug conjugate targets B7-H3 (CD276) and delivers a topoisomerase I inhibitor payload.
ClinicalTrials.gov ID: NCT06330064
TrialFetch AI summary: Adults with previously untreated stage IV squamous or nonsquamous NSCLC receive pembrolizumab-based therapy, with chemotherapy according to histology. Investigational combinations add the TIGIT inhibitor vibostolimab, CD27 agonist boserolimab, ILT4 inhibitor MK-4830, or ILT3 inhibitor MK-0482 to pembrolizumab and chemotherapy, or pair pembrolizumab with the B7-H3–directed antibody–drug conjugate ifinatamab deruxtecan or the HER3-directed antibody–drug conjugate HER3-DXd, with or without carboplatin.
ClinicalTrials.gov ID: NCT04165070