First-in-human Study of S-588210 (S-488210+S-488211)
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|ClinicalTrials.gov Identifier: NCT04316689|
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Head and Neck Cancer Bladder Cancer Esophageal Cancer Mesothelioma||Biological: S-488210 Biological: S-488211||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Phase 1 Study of S-488210/S-488211 to Evaluate the Safety and Tolerability in Patients With Unresectable Recurrent and/or Metastatic Solid Tumor|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: S-588210 (S-488210 + S-488211)
Participants will receive subcutaneous injections once a week for 4 weeks and then a biweekly extension treatment for 8 weeks. Each treatment will consist of 1 subcutaneous injection of 1 mL of S- 488210 and 1 subcutaneous injection of 1 mL of S-488211 containing 1 mg each of the 5 peptides.
S-488210 is a freeze-dried injectable formulation containing the following three peptides, S-488201 (a URLC10-derived peptide), S-488202 (a CDCA1-derived peptide) and S-488203 (a KOC1-derived peptide).
Other Name: S-588210
S-488211 is a freeze-dried injectable formulation containing the following two peptides, S-488204 (a DEPDC1-derived peptide) and S-488205 (an MPHOSPH1-derived peptide).
Other Name: S-588210
- Number of Participants with Adverse Events [ Time Frame: Up to 16 weeks ]Adverse events will be classified by system organ class and preferred term using Medical Dictionary for Regulatory Activities (MedDRA).
- Cytotoxic T Lymphocyte (CTL) Induction Rate [ Time Frame: Baseline and Weeks 8 and 12 ]CTL induction is defined as the increase in CTL activity at any point after baseline. Accordingly, the CTL induction rate is calculated as the percentage of participants who show CTL induction to at least any of the 5 antigens.
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): NCT04316689
|Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line||800-849-9707||Shionogiclintrialsfirstname.lastname@example.org|
|University College London Clinical Research Facility||Recruiting|
|London, United Kingdom, W1T 7HA|
|Study Director:||Shionogi Clinical Trials Administrator Clinical Support Help Line||Shionogi|