Rahul Aggarwal
This is a Phase 2, open-label, single-arm study evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) in adult men with histologic evidence of de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). I-DXd is an investigational antibody-drug conjugate (ADC) designed to target B7-H3, a protein found at high levels on many neuroendocrine prostate cancer cells. After binding to B7-H3, I-DXd delivers an anticancer drug called deruxtecan (DXd) to tumor cells. DXd interferes with an enzyme called topoisomerase I, which is involved in DNA replication and repair. This causes DNA damage that can lead to cancer cell death.
PRIMARY OBJECTIVE: I. To determine the objective response rate of I-DXd in de novo or treatment-emergent metastatic neuroendocrine prostate cancer. SECONDARY OBJECTIVES: I. To determine the median duration of response. II. To estimate the median radiographic progression-free survival and 6- and 12- month radiographic progression-free survival rates by investigator assessment. III. To evaluate the safety of I-DXd in patients with neuroendocrine prostate cancer. IV. To evaluate the PSA50 and PSA90 response rate in the subset of patients with baseline serum PSA greater than 5 ng/mL. V. To e…
Inclusion Criteria: 1. Age ≥18 years 2. Documentation of Histologic or molecular evidence of neuroendocrine prostate cancer (NEPC), defined by at least one of the following: 1. Small cell or large cell neuroendocrine cancer by morphology 2. ≥20% tumor expression of Insulinoma-Associated Protein 1(INSM1), synaptophysin, or Cluster of Differentiation 56 (CD56) 3. Genomic alterations in ≥2 of RB Transcriptional Corepressor 1(RB1), Tumor Protein p53 (TP53), or phosphatase and tensin homolog (PTEN). Patients only meeting criterion 2(c) will be capped at no more than 30% of the effica…
Given intravenously (IV)
Undergo Imaging
Undergo Imaging
Undergo Imaging
Perform blood draw
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.