Clinical trial · Interventional
A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer
A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer
NCT02454010CI-TRIAL-00088113completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FF21101 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Lowest dose of FF-21101(90Y)
- description
- In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
- interventionNames
- Biological: FF21101
- type
- EXPERIMENTAL
- label
- 2X Lowest dose of FF-21101(90Y)
- description
- In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose
- interventionNames
- Biological: FF21101
- type
- EXPERIMENTAL
- label
- 3X Lowest dose of FF-21101(90Y)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMahalingam 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