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

FujiFilm

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Biological: FF21101

Study type: Interventional

Funder types: Industry

Identifiers

NCT02454010

FF21101US101

Details and patient eligibility

About

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.

Full 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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 7 patient groups

Lowest dose of FF-21101(90Y)

Experimental group

Description:

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

Treatment:

Biological: FF21101

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

Experimental group

Description:

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

Treatment:

Biological: FF21101

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

Experimental group

Description:

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

Treatment:

Biological: FF21101

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

Experimental group

Description:

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

Treatment:

Biological: FF21101

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

Experimental group

Description:

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

Treatment:

Biological: FF21101

Expansion Phase (Cohort 6), Ovarian

Experimental group

Description:

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)

Treatment:

Biological: FF21101

Expansion Phase (Cohort 7), Adv Tumors

Experimental group

Description:

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)

Treatment:

Biological: FF21101