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Trial Summary

Protocol No.ASG-22CE-13-2
StatusOPEN TO ACCRUAL
Principal InvestigatorPili, Roberto
ScopeNational
PhasePhase I
Age GroupAdult
TitleA Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects with Metastatic Urothelial Cancer and Other Malignant Solid Tumors that Express Nectin-4
DescriptionThe purpose of this study is to evaluate the safety and pharmacokinetics ASG-22CE as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid tumors.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Dose Escalation, Cis-ineligible and CPI-Treated Expansion cohorts: Subjects must have histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
  • Ovarian Expansion Cohort: Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who have previously progressed while receiving or within 6 months of completing a platinum-containing regimen.
  • NSCLC Expansion Cohort: Subjects must have histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified)
  • For Dose Escalation, Cis-ineligible and CPI-Treated Expansion Cohorts, subjects must submit a tumor tissue for Nectin-4 expression; however, the results are not required for enrollment.
  • For the NSCLC and Ovarian Expansion Cohorts: Subjects must have tumor tissue positive (IHC H-score ≥150) for Nectin-4 expression
  • For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
  • For the Cis-ineligible Expansion Cohort: Subject must not have received any prior lines of chemotherapy (prior treatment with immunotherapy is allowed).
  • For the CPI-Treated Expansion Cohort: Subject must have received prior treatment with a CPI in the metastatic setting.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBladder Cancer
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment