A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer

Solid Tumor Clinical Trial

Official title:

A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454010
• Other study ID #: FF21101US101
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: October 2021

Study information

• Verified date: April 2022
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.

Description:

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors. This is an open label study that will recruit approx 70 patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females = 18 years of age

• Histologically or cytologically confirmed advanced solid tumor malignancy, refractory or relapsed from prior therapy, or for whom no alternative therapy is available

• At least 4 weeks beyond the last chemotherapy (or = 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (= Grade 1)

• Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior to study

• At least one measurable disease site that meets target lesion requirements

• Adequate performance status: Eastern Cooperative Oncology Group (ECOG) = 2

• Life expectancy of = 3 months

• Adequate hematologic parameters without ongoing transfusional support:

• Negative serum pregnancy test

• Ability to provide written informed consent

Exclusion Criteria:

• Previous radioimmunotherapy. Previous antibody-based therapy is allowed as long as = 28 days has elapsed from last dose to study treatment.

• Prior radiation to > 30% of the red marrow or to maximal tolerable level for any organ

• Serious cardiac condition within the last 6 months

• Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient

• History of retinal degenerative disease, history of uveitis, history of retinal vein occlusion (RVO), or any eye condition that would be considered a risk factor for RVO or has medically relevant abnormalities identified on screening ophthalmologic examination

• Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior, or currently treated brain metastases are allowed.

• Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)

• Known autoimmune disease

• Active infection requiring intravenous (IV) antibiotic usage within the last week prior to the dosimetry portion of the study

• Corticosteroid use within 2 weeks of study treatment

• Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study results

• Pregnant or breast-feeding

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Biological:
• FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)

Locations

Country	Name	City	State
United States	Winship Cancer Institute - Emory University	Atlanta	Georgia
United States	Northwestern University - Feinberg School of Medicine	Chicago	Illinois
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Pharmaceuticals U.S.A., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity	measurement of CDH3 expression	Single sample taken at enrollment
Primary	Safety and tolerability of radio-labeled FF21101	measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity	28 days
Secondary	Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)	Overall response rates are defined as the number of patients achieving a best response of complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD])	8 weeks