Ifinatamab deruxtecan

HealthScout AI summary: Adults with metastatic castration-resistant prostate adenocarcinoma (taxane-naive in the mCRPC setting) after 1–2 AR pathway inhibitors are randomized to ifinatamab deruxtecan (I-DXd, a B7-H3–targeting antibody–drug conjugate delivering a topoisomerase I inhibitor) alone or combined with MK-5684 (opevesostat, a CYP11A1 inhibitor suppressing steroidogenesis) or an ARPI (abiraterone or enzalutamide) versus docetaxel. Key exclusions include prior ILD/pneumonitis and prior taxane for mCRPC; endpoints include safety, PSA50, and radiographic efficacy.

ClinicalTrials.gov ID: NCT06863272

HealthScout AI summary: This trial enrolls adults with stage IV squamous NSCLC whose disease has progressed after both anti-PD-(L)1 immunotherapy and platinum chemotherapy, randomizing them to either standard docetaxel or investigational antibody-drug conjugates: Raludotatug deruxtecan (targeting CDH6) or Infinatamab deruxtecan (targeting B7-H3).

ClinicalTrials.gov ID: NCT06780098

HealthScout AI summary: Adults with metastatic castration-resistant prostate cancer progressing after ADT and 1–2 prior AR pathway inhibitors (no prior taxane for mCRPC) are randomized to ifinatamab deruxtecan (I-DXd), a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus docetaxel plus prednisone. Key exclusions include prior steroid-requiring ILD/pneumonitis and significant cardiovascular disease; primary endpoints are OS and rPFS.

ClinicalTrials.gov ID: NCT06925737

HealthScout AI summary: This trial enrolls adults with stage IV nonsquamous NSCLC who have progressed after both anti-PD-(L)1 therapy and platinum-based chemotherapy, randomizing them to receive either raludotatug deruxtecan (a CDH6-targeting antibody-drug conjugate), ifinatamab deruxtecan (a B7-H3-targeting antibody-drug conjugate), or standard docetaxel. Patients with EGFR, ALK, or ROS1 alterations eligible for targeted therapy are excluded.

ClinicalTrials.gov ID: NCT06780085

HealthScout AI summary: Adults with unresectable or metastatic ESCC after exactly one prior platinum-based chemo plus immune checkpoint inhibitor are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus investigator’s choice of docetaxel, paclitaxel, or irinotecan. Key eligibility includes ECOG 0–1, measurable disease, and exclusion of prior B7‑H3 or topo I agents and significant ILD/pneumonitis or CNS disease.

ClinicalTrials.gov ID: NCT06644781

HealthScout AI summary: Adults with relapsed/refractory extensive-stage SCLC after ≥1 prior systemic therapy (including platinum) receive gocatamig (HPN328; trispecific DLL3×CD3 T‑cell engager with albumin-binding for half-life) as monotherapy or combined with ifinatamab deruxtecan (B7‑H3–targeted DXd ADC) or with durvalumab (PD‑L1 inhibitor). Key exclusions include uncontrolled effusions, significant/suspected ILD/pneumonitis, major cardiopulmonary disease/events, uncontrolled brain mets, active infections/viral hepatitis, and recent chemo/radiation; archival or fresh tumor tissue required.

ClinicalTrials.gov ID: NCT06780137

HealthScout AI summary: Adults with extensive-stage SCLC either starting first-line therapy or entering maintenance after carboplatin/etoposide/atezolizumab receive the B7-H3–targeted ADC ifinatamab deruxtecan (DXd topoisomerase I payload) plus atezolizumab, with carboplatin added during induction for treatment‑naive patients; key exclusions include prior B7-H3 therapy, uncontrolled brain mets, ILD/pneumonitis, and active autoimmune disease. The trial evaluates safety and dose of I-DXd in combination regimens and explores efficacy as induction and/or maintenance.

ClinicalTrials.gov ID: NCT06362252

HealthScout AI summary: Adults with extensive-stage SCLC who have relapsed after exactly one prior platinum-based regimen (ECOG 0–1, measurable disease, no active/untreated CNS disease) are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus physician’s choice (topotecan, lurbinectedin, or amrubicin). Key exclusions include prior B7-H3 therapy, prior topoisomerase I inhibitor, ILD/pneumonitis, significant cardiac or corneal disease.

ClinicalTrials.gov ID: NCT06203210

HealthScout AI summary: This trial enrolls adults with recurrent or metastatic solid tumors—including endometrial, head and neck, pancreatic, colorectal, hepatocellular, gastric, urothelial, ovarian, cervical, biliary tract, certain subtypes of breast cancer, and cutaneous melanoma—whose disease has progressed after standard therapy and who have measurable, biopsiable disease. All patients receive ifinatamab deruxtecan, an investigational B7-H3-directed antibody-drug conjugate delivering a topoisomerase I inhibitor, administered intravenously every three weeks.

ClinicalTrials.gov ID: NCT06330064

HealthScout AI summary: Adults with DLL3-expressing advanced neuroendocrine cancers—including relapsed/refractory SCLC after platinum, treatment-emergent or de novo neuroendocrine prostate cancer, and other high-grade NETs lacking effective options—receive gocatamig (HPN328), a trispecific T-cell engager targeting DLL3/CD3 with albumin-binding for half-life, as IV monotherapy on varied schedules or in combination with atezolizumab (PD-L1 inhibitor) or ifinatamab deruxtecan (B7-H3 ADC). Key exclusions include active/untreated CNS disease, significant autoimmune/immunosuppression, recent major cardiovascular events, uncontrolled viral infections, and interstitial lung disease.

ClinicalTrials.gov ID: NCT04471727

HealthScout AI summary: This trial enrolls adults with previously untreated stage IV squamous or non-squamous NSCLC (without targetable driver mutations) to receive pembrolizumab plus chemotherapy combined with an investigational immunotherapy or antibody-drug conjugate targeting TIGIT (vibostolimab), CD27 (boserolimab), ILT4 (MK-4830), ILT3 (MK-0482), B7-H3 (I-DXd), or HER3 (HER3-DXd). Patients must have available tumor tissue and good organ function; those with active CNS disease, significant comorbidities, or prior systemic therapy for metastatic NSCLC are excluded.

ClinicalTrials.gov ID: NCT04165070