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

NCT04316689 | Completed Phase 1 DMC

• 1 other identifier: 1801P2011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Head and Neck Cancer; Bladder Cancer; Esophageal Cancer; Mesothelioma

Keywords

Metastatic solid tumor; Unresectable recurrent solid tumor; S-588210; Peptide vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

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

  Up to 16 weeks

Secondary Outcomes (1)

• Cytotoxic T Lymphocyte (CTL) Induction Rate

  Baseline and Weeks 8 and 12

Study Arms (1)

S-588210 (S-488210 + S-488211)

EXPERIMENTAL

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.

Biological: S-488210; Biological: S-488211

Interventions

S-488210 BIOLOGICAL

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).

Also known as: S-588210

S-588210 (S-488210 + S-488211)

S-488211 BIOLOGICAL

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).

Also known as: S-588210

S-588210 (S-488210 + S-488211)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unresectable recurrent and/or metastatic solid tumor of lung, esophageal, head and neck, mesothelioma, or bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra), who have progressed after conventional systemic therapies or have exhausted or are intolerant to existing treatment options.
• Human leukocyte antigen (HLA)-A\*02:01-positive patients.
• Patients who are male or female aged ≥18 years at the time of informed consent.
• Patients with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at enrollment.
• Patients who have a lymphocyte count accounting for 15% or higher of the total white blood cell count within 28 days before enrollment.
• Patients who provide a personally signed and dated informed consent document for participation in the study.
• Patients with expected life-span of at least 3 months from the time of enrollment.

You may not qualify if:

• Patients who are expected to require any of the following therapies between enrollment and completion of the Observation Period.
• Anti-malignant tumor drug
• Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone ≤ 10 mg/day orally)
• Systemic immunosuppressant drug
• Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the cancer(s)
• Surgical therapy for the cancer(s)
• Hyperthermia for the cancer(s)
• Traditional Chinese herbal medicine with anti-tumor or immunosuppressant effect
• Other investigational products
• Patients who have severe concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with cancer(s).
• Patients who have known human immunodeficiency virus infection.
• Patients with uncontrolled systemic or active infection.
• Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
• Patients with a history or evidence of autoimmune diseases and/or immunodeficiencies.
• Female patients who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

University College London Clinical Research Facility

London, W1T 7HA, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Mesothelioma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: July 30, 2019
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

GB (1)