A Phase II/III, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: II/III
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Kimberly Myers
kimyers@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06161025?term=NCT06161025&viewType=Card&rank=1#participation-criteria
Summary
Primary
To evaluate BICR-assessed ORR at each dose level of R-DXd
Secondary
To evaluate investigator assessed ORR at each dose level of R-DXd
To evaluate the DoR at each dose level of R-DXd
To evaluate PFS at each dose level of R-DXd
To assess disease control rate (DCR) at each dose level of R-DXd
To evaluate OS at each dose level of R-DXd
To assess the safety and tolerability of R-DXd
To characterize the PK of R-DXd following single and multiple dose administration
To assess the immunogenicity of RDXd
To assess CA-125 response rate at each dose level of R-DXd
To evaluate CDH6 protein expression in tumor tissue and its correlation with efficacy
Exploratory
To explore antitumor activity by tumor imaging of R-DXd
To investigate pharmacodynamic changes, biomarkers of response and resistance, and mechanism of action of R-DXd
To evaluate the E-R and PK-PD relationships for efficacy, safety, and biomarker endpoints
To assess QoL using standardized PRO instruments
To evaluate patient reported symptomatic toxicity