Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Esophageal Neoplasms

Recurrence

Urinary Bladder Neoplasms

Head and Neck Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Esophageal Cancer

Malignant Mesothelioma

All Drugs and Chemicals

Vaccines

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).

S-488210

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).

S-488211

Shionogi Clinical Trials Administrator Clinical Support Help Line

The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.

First-in-human Study of S-588210 (S-488210+S-488211)

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

Adverse events will be classified by system organ class and preferred term using Medical Dictionary for Regulatory Activities (MedDRA).

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.

Shionogi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-human Study of S-588210 (S-488210+S-488211)	NCT04316689	Lung Cancer Head and Neck C... Bladder Cancer Esophageal Canc... Mesothelioma	S-488210 S-488211	18 Years -	Shionogi Inc.
First-in-human Study of S-588210 (S-488210+S-488211)	NCT04316689	Lung Cancer Head and Neck C... Bladder Cancer Esophageal Canc... Mesothelioma	S-488210 S-488211	18 Years -	Shionogi Inc.

Spots Global Cancer Trial Database for unresectable recurrent solid tumor