Clinical Trials /

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

NCT04316689

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Esophageal Carcinoma
  • Head and Neck Carcinoma
  • Lung Carcinoma
  • Mesothelioma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-human Study of S-588210 (S-488210+S-488211)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 1801P2011
  • NCT ID: NCT04316689

Conditions

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

Interventions

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

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
S-588210 (S-488210 + S-488211)ExperimentalParticipants 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
  • S-488211

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events
Time Frame:Up to 16 weeks
Safety Issue:
Description:Adverse events will be classified by system organ class and preferred term using Medical Dictionary for Regulatory Activities (MedDRA).

Secondary Outcome Measures

Measure:Cytotoxic T Lymphocyte (CTL) Induction Rate
Time Frame:Baseline and Weeks 8 and 12
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shionogi

Trial Keywords

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

Last Updated

March 19, 2020