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Protocol No.16101GCCPrincipal InvestigatorMannuel, Heather
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.
TreatmentExperimental: Part A ASG-22CE Dose Escalation (Dose Levels 1-4) Experimental: Part B ASG-22CE Cisplatin Therapy-Ineligible Expansion Experimental: Part B ASG-22CE Non Small Cell Lung Cancer Expansion Experimental: Part B ASG-22CE Ovarian Cancer Expansion Experimental: Part C ASG22CE Immune Checkpooint Inhibitor (CPI) Treated Expa
Key EligibilityInclusion 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 of greater than or equal to 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.
-Subjects must have measurable disease according to RECIST (version 1.1)
-For Dose Escalation, NSCLC, Ovarian, and CPI Treated Expansion Cohorts: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-For the Cis-ineligible expansion Cohort: Subject must have an ECOG performance status of less than or equal to 2
-Life expectancy of greater than or equal to 3 months
-Negative pregnancy test (women of childbearing potential)
-Hematologic function
-Renal function, as follows
-Total bilirubin less than or equal to 1.5 x ULN (upper limit of normal)
-Serum albumin greater than or equal to 2.5 g/dL
-Aspartate aminotransferase (AST) less than or equal to 1.5 x ULN
-Alanine aminotransferase (ALT) less than or equal to 1.5 x ULN
-International normal ratio (INR) < 1.3 or less than or equal to institutional ULN (or less than or equal to 3.0 if on therapeutic anticoagulation)
-Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
-Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form

More eligibility criteria can be found by going to clinicaltrials.gov and searching: NCT02091999
Applicable Disease SitesBladder
Lung
Ovary
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02091999
ContactGreenebaum Cancer Center Shelle Besche, RN, BSN, OCN, CCRP Phone:410-328-8610
Pager:410-328-2337 #11582
Email:mbesche@umm.edu
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