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

NCT02454010 | Completed Phase 1 DMC

• 1 other identifier: FF21101US101
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)

  8 weeks

Other Outcomes (1)

• Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity

  Single sample taken at enrollment

Study Arms (7)

Lowest dose of FF-21101(90Y)

EXPERIMENTAL

In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101

Biological: FF21101

2X Lowest dose of FF-21101(90Y)

EXPERIMENTAL

In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose

Biological: FF21101

3X Lowest dose of FF-21101(90Y)

EXPERIMENTAL

In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose

Biological: FF21101

4X Lowest dose of FF-21101(90Y)

EXPERIMENTAL

In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose

Biological: FF21101

5X Lowest dose of FF-21101(90Y)

EXPERIMENTAL

In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 5X the lowest dose

Biological: FF21101

Expansion Phase (Cohort 6), Ovarian

EXPERIMENTAL

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)

Biological: FF21101

Expansion Phase (Cohort 7), Adv Tumors

EXPERIMENTAL

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)

Biological: FF21101

Interventions

FF21101 BIOLOGICAL

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

2X Lowest dose of FF-21101(90Y); 3X Lowest dose of FF-21101(90Y); 4X Lowest dose of FF-21101(90Y); 5X Lowest dose of FF-21101(90Y); Expansion Phase (Cohort 6), Ovarian; Expansion Phase (Cohort 7), Adv Tumors; Lowest dose of FF-21101(90Y)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujifilm Pharmaceuticals U.S.A., Inc.: lead

Study Sites (4)

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Mahalingam D, Owonikoko TK, Delpassand E, Mulcahy MF, Kalyan A, Ulahannan S, Cheung K, Izumi Y, Johansen M, Madden T, Shimoyama S, Subach RA, Suzuki T, Wages DS, Wheeler C, Richardson DL. A trial of radiolabeled antibody yttrium-90-FF-21101 for the treatment of advanced ovarian and other cancers. Cancer. 2025 Jan 1;131(1):e35680. doi: 10.1002/cncr.35680.

  PMID: 39748726 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 27, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)