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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Biological: FF21101

• Registration Number: NCT02454010
• Lead Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Study Start: 2016-01
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5X Lowest dose of FF-21101(90Y)	FF21101	In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 5X the lowest dose
Expansion Phase (Cohort 6), Ovarian	FF21101	In the expansion phase, subjects in this cohort will be diagnosed with epithelial ovarian, peritoneal or fallopian tube carcinoma and will receive a dose of 25 mCi/m2 FF-21101(90Y)
2X Lowest dose of FF-21101(90Y)	FF21101	In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose
Lowest dose of FF-21101(90Y)	FF21101	In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
4X Lowest dose of FF-21101(90Y)	FF21101	In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose
3X Lowest dose of FF-21101(90Y)	FF21101	In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose
Expansion Phase (Cohort 7), Adv Tumors	FF21101	In the expansion phase, subjects in this cohort will be diagnosed with triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), biliary cancer (cholangiocarcinoma or gall bladder carcinoma), pancreatic carcinoma, colorectal cancer and will receive a dose of 25 mCi/m2 FF-21101(90Y)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of radio-labeled FF21101	28 days	measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)	8 weeks	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 \[PD\])

Trial Locations

Locations (4)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Northwestern University - Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Winship Cancer Institute - Emory University; 🇺🇸 Atlanta, Georgia, United States