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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
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: S-488210
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

Biological: S-488211
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Human leukocyte antigen (HLA)-A*02:01-positive patients.
  3. Patients who are male or female aged ≥18 years at the time of informed consent.
  4. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at enrollment.
  5. Patients who have a lymphocyte count accounting for 15% or higher of the total white blood cell count within 28 days before enrollment.
  6. Patients who provide a personally signed and dated informed consent document for participation in the study.
  7. Patients with expected life-span of at least 3 months from the time of enrollment.

Exclusion Criteria:

  1. 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
  2. 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).
  3. Patients who have known human immunodeficiency virus infection.
  4. Patients with uncontrolled systemic or active infection.
  5. Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
  6. Patients with a history or evidence of autoimmune diseases and/or immunodeficiencies.
  7. Female patients who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations.
  8. Patients who are considered ineligible for this study by the investigator or subinvestigator due to any reasons, including inability to understand and follow the requirements of the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line 800-849-9707 Shionogiclintrials-admin@shionogi.co.jp

Locations
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United Kingdom
University College London Clinical Research Facility Recruiting
London, United Kingdom, W1T 7HA
Sponsors and Collaborators
Shionogi
Investigators
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Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
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Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT04316689    
Other Study ID Numbers: 1801P2011
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shionogi Inc. ( Shionogi ):
Metastatic solid tumor
Unresectable recurrent solid tumor
S-588210
Peptide vaccine
Additional relevant MeSH terms:
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Mesothelioma
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial