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

Primary Purpose

Lung Cancer, Head and Neck Cancer, Bladder Cancer

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

S-488210

S-488211

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Metastatic solid tumor, Unresectable recurrent solid tumor, S-588210, Peptide vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

University College London Clinical Research Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cytotoxic T Lymphocyte (CTL) Induction Rate

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.

Full Information

NCT ID

NCT04316689

First Posted

March 19, 2020

Last Updated

January 25, 2022

Sponsor

Shionogi

1. Study Identification

Unique Protocol Identification Number

NCT04316689

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

September 22, 2021 (Actual)

Study Completion Date

September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shionogi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

S-488210

Other Intervention Name(s)

S-588210

Intervention Description

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).

Intervention Type

Biological

Intervention Name(s)

S-488211

Other Intervention Name(s)

S-588210

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

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

Time Frame

Up to 16 weeks

Secondary Outcome Measure Information:

Title

Cytotoxic T Lymphocyte (CTL) Induction Rate

Description

Time Frame

Baseline and Weeks 8 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shionogi Clinical Trials Administrator Clinical Support Help Line

Organizational Affiliation

Shionogi

Official's Role

Study Director

Facility Information:

Facility Name

University College London Clinical Research Facility

City

London

ZIP/Postal Code

W1T 7HA

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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