Lung CancerPhase 1NCT04316689
First-in-human Study of S-588210 (S-488210+S-488211)
A Phase 1 study testing S-488210 and S-488211 in people with Lung Cancer and Head and Neck Cancer, run by Shionogi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer, Bladder Cancer
- What is being tested?
- S-488210 and S-488211
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2019to 22 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Clinical Research Facility
London, W1T 7HA
About this study
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
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.
- Being tested
- S-488210, S-488211
- Keywords
- Metastatic solid tumor, Unresectable recurrent solid tumor, S-588210, Peptide vaccine
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Urinary Bladder Neoplasms, Esophageal Neoplasms, Mesothelioma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-488210Biological
Also called S-588210
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).
S-488211Biological
Also called S-588210
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: S-488210; Biological: S-488211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 16 weeks
Secondary outcomes (1)
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.
Measured: Baseline and Weeks 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start30 Jul 2019
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316689
- Sponsor's protocol ID
- 1801P2011
- Status last verified
- Jan 2022
- First submitted
- 19 Mar 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04316689
- Acronym / sponsor ID
- 1801P2011
- Keywords
- Metastatic solid tumor, Unresectable recurrent solid tumor, S-588210, Peptide vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-588210 (S-488210 + S-488211) | Experimental | Biological: S-488210, Biological: S-488211Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- Patients who are expected to require any of the following therapies between enrollment and completion of the Observation Period.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-488210Also: S-588210S-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). | Biological | S-588210 (S-488210 + S-488211) |
| S-488211Also: S-588210S-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). | Biological | S-588210 (S-488210 + S-488211) |
Primary outcome
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).
1 secondary outcome
Cytotoxic T Lymphocyte (CTL) Induction Rate
Time frame: Baseline and Weeks 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-488210 and S-488211 in people with Lung Cancer and Head and Neck Cancer, run by Shionogi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.