Solid TumorPhase 1NCT02454010
A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer
A Phase 1 study testing FF21101 in people with Solid Tumor, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- FF21101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Life expectancy of ≥ 3 months
- Adequate hematologic parameters without ongoing transfusional support:
- Negative serum pregnancy test
- Ability to provide written informed consent
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer
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.
Read the 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
- Conditions
- Solid Tumor
- Being tested
- FF21101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF21101Biological
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
| Study group | Role | What they receive |
|---|---|---|
| Lowest dose of FF-21101(90Y) | Experimental | In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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) Receives: 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) Receives: Biological: FF21101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (1)
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])
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454010
- Sponsor's protocol ID
- FF21101US101
- Status last verified
- Apr 2025
- First submitted
- 4 May 2015
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39748726
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer
- ClinicalTrials.gov ID
- NCT02454010
- Acronym / sponsor ID
- FF21101US101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lowest dose of FF-21101(90Y) | Experimental | Biological: FF21101In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 |
| 2X Lowest dose of FF-21101(90Y) | Experimental | Biological: FF21101In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose |
| 3X Lowest dose of FF-21101(90Y) | Experimental | Biological: FF21101In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose |
| 4X Lowest dose of FF-21101(90Y) | Experimental | Biological: FF21101In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose |
| 5X Lowest dose of FF-21101(90Y) | Experimental | Biological: FF21101In 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 | Experimental | Biological: FF21101In 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) |
| Expansion Phase (Cohort 7), Adv Tumors | Experimental | Biological: FF21101In 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FF21101(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene) | Biological | 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) |
Primary outcome
Safety and tolerability of radio-labeled FF21101
Time frame: 28 days
measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity
1 secondary outcome
Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 39748726Mahalingam 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.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FF21101 in people with Solid Tumor, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of radio-labeled FF21101 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.