Phase I Study of Radiolabeled OTSA101-DTPA in Patients With Relapsed or Refractory Synovial Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04176016|
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : December 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Synovial Sarcoma||Drug: OTSA101-DTPA-111In Drug: OTSA101-DTPA-90Y||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
|Experimental: Single Study Arm, no competitor||
single IV injection, 185MBq/body
IV injection (max. 3 injections per patient), 1110MBq/body
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176016
|Contact: OncoTherapy Sciencefirstname.lastname@example.org|
|Osaka International Cancer Institute||Recruiting|
|Contact: Satoshi Takenaka, M.D. See Central Contact|
|Cancer Institute Hospital of JFCR||Recruiting|
|Contact: Keisuke Ae, M.D.|
|National Cancer Center Hospital||Recruiting|
|Contact: Kan Yonemori, M.D See Central Contact|