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

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of Participants with Adverse Events

Secondary Outcome

 Cytotoxic T Lymphocyte (CTL) Induction Rate

Condition

Lung Cancer

Intervention

S-488210

Study Arms / Comparison Groups

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

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

10

Start Date

July 30, 2019

Completion Date

October 31, 2020

Primary Completion Date

October 31, 2020

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line, 800-849-9707, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT04316689

Organization ID

1801P2011

Responsible Party

Sponsor

Study Sponsor

Shionogi

Study Sponsor

Shionogi Clinical Trials Administrator Clinical Support Help Line, Study Director, Shionogi

Verification Date

March 2020