Relapsed or Refractory Synovial SarcomaPhase 1NCT04176016
Phase I Study of Radiolabeled OTSA101-DTPA in Patients With Relapsed or Refractory Synovial Sarcoma
A Phase 1 study testing OTSA101-DTPA-111In and OTSA101-DTPA-90Y in people with Relapsed or Refractory Synovial Sarcoma, run by OncoTherapy Science, Inc. at 3 sites in Japan.
Trial summary
The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Synovial Sarcoma
- What is being tested?
- OTSA101-DTPA-111In and OTSA101-DTPA-90Y
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesJapan
- Study dates
- 10 Jan 2020to 11 Jan 2024
- 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
- Patients with a documented relapsed or refractory synovial sarcoma after standard chemotherapy
- Patients ≥18 years of age at the time of obtaining informed consent
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Patients with measurable lesion
- Patients not received any anti-malignancy agent or specified surgical intervention within 28 days or specified radiotherapy within 14 days prior to study registration.
- Patients without any clinically significant laboratory abnormality.
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- Patients with adequate heart function as measured by echocardiography or multiple gated acquisition scan (MUGA).
- Patients with adequate pulmonary function as measured by pulmonary function tests.
- Patients who are either not of childbearing potential or who agree to use a contraception method during the study and for 12 months after the last dose of study drug
- Patients must be able to understand and be willing to sign a written informed consent
Who cannot join
- Patients with documented concurrent malignancy.
- Patients with brain metastasis with clinical symptoms.
- Patients with any infection requiring systemic treatment.
- Patients with lung inflammation or pulmonary fibrosis.
- Patients with a known history of hypersensitivities to antibody agents or serum albumin agents.
- Patients with a known history of autoimmune diseases.
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- Patients with myocardial infarction (MI) within 6 months prior to study registration.
- Patients with uncontrolled diseases.
- Patients with any disease requiring continuous systemic administration of steroids or immunosuppressants.
- Patients with evidence of active HBV, HCV or HIV infection.
- Pregnant or breastfeeding female patients, or female patients with suspected pregnancy.
- Patients who are participating any other investigational treatments during the study.
- Patients with psychiatric disorders and is considered to have difficulty to study participation.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Osaka International Cancer Institute
Osaka
Cancer Institute Hospital of JFCR
Tokyo
National Cancer Center Hospital
Tokyo
About this study
Official title: Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma
The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.
- Conditions
- Relapsed or Refractory Synovial Sarcoma
- Being tested
- OTSA101-DTPA-111In, OTSA101-DTPA-90Y
- Medical subject headings
- Recurrence, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTSA101-DTPA-111InDrug
single IV injection, 185MBq/body
OTSA101-DTPA-90YDrug
IV injection (max. 3 injections per patient), 1110MBq/body
| Study group | Role | What they receive |
|---|---|---|
| Single Study Arm, no competitor | Experimental | Not described Receives: Drug: OTSA101-DTPA-111In; Drug: OTSA101-DTPA-90Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.
Measured: up to 72 hours post dosing
Safety of OTSA101-DTPA-111In
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Measured: up to 10 days post dosing
Safety of OTSA101-DTPA-90Y
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Measured: up to 6 weeks post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start10 Jan 2020
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Why it stopped: Some of the raw materials for the investigational drug are difficult to obtain and expensive.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Synovial SarcomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoTherapy Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176016
- Sponsor's protocol ID
- OTS3050102
- Status last verified
- Jan 2024
- First submitted
- 20 Nov 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma
- ClinicalTrials.gov ID
- NCT04176016
- Acronym / sponsor ID
- OTS3050102
- Conditions
- Relapsed or Refractory Synovial Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Some of the raw materials for the investigational drug are difficult to obtain and expensive.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- OncoTherapy Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 25 Nov 2019 (actual)
- 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 evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Arm, no competitor | Experimental | Drug: OTSA101-DTPA-111In, Drug: OTSA101-DTPA-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)
- Patients with a documented relapsed or refractory synovial sarcoma after standard chemotherapy
- Patients ≥18 years of age at the time of obtaining informed consent
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Patients with measurable lesion
- Patients not received any anti-malignancy agent or specified surgical intervention within 28 days or specified radiotherapy within 14 days prior to study registration.
Key exclusion criteria (13 listed)
- Patients with documented concurrent malignancy.
- Patients with brain metastasis with clinical symptoms.
- Patients with any infection requiring systemic treatment.
- Patients with lung inflammation or pulmonary fibrosis.
- Patients with a known history of hypersensitivities to antibody agents or serum albumin agents.
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 |
|---|---|---|
| OTSA101-DTPA-111Insingle IV injection, 185MBq/body | Drug | Single Study Arm, no competitor |
| OTSA101-DTPA-90YIV injection (max. 3 injections per patient), 1110MBq/body | Drug | Single Study Arm, no competitor |
Primary outcome
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
Time frame: up to 72 hours post dosing
Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.
Safety of OTSA101-DTPA-111In
Time frame: up to 10 days post dosing
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Safety of OTSA101-DTPA-90Y
Time frame: up to 6 weeks post dosing
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Results and safety
The study was stopped early (reason given: Some of the raw materials for the investigational drug are difficult to obtain and expensive.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
3 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 OTSA101-DTPA-111In and OTSA101-DTPA-90Y in people with Relapsed or Refractory Synovial Sarcoma, run by OncoTherapy Science, Inc. at 3 sites in Japan.
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 13 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: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 was stopped early (reason given: Some of the raw materials for the investigational drug are difficult to obtain and expensive.). Results are not available in the source record.
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?
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In (time frame: up to 72 hours post dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.