RECRUITING

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

Conditions

Solid Tumors C-C motif chemokine receptor 8 (CCR8)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D.

Official Title

A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2022-05-30

Study Completion:2027-04-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05101070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female participant must be at least 18 years of age inclusive (or complies with country-specific regulatory requirements), at the time of signing the informed consent. 2. Participants with histologically or cytologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical benefit, or who are intolerant to or unwilling to receive these therapies for any reasons. 3. Measurable disease by RECIST 1.1. 4. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma (UC), non-small cell lung cancer (NSCLC), or triple-negative breast cancer (TNBC), esophageal cancer (EC; esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (GC; gastric and gastroesophageal junction adenocarcinoma). 5. (Part B only) Participants should have 1 of specific histologically or cytologically confirmed tumor types selected by the sponsor after the determination of tentative RP2D(s) in Part A-1. 6. (Part C only) Participants should have 1 of specific histologically or cytologically confirmed tumor types selected by the sponsor after the determination of tentative RP2D(s) in Part A-2. 7. Participants should be willing and able to provide permission to access archival formalin-fixed paraffin-embedded (FFPE) tumor tissues (as block or unstained slides) for this study. 8. Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples. 9. (At selected sites only) Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples. Fresh tissue samples are required as these will be used for the proof of mechanism analysis. 10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 11. An estimated life expectancy of at least 12 weeks. 12. Adequate hematologic and organ function as confirmed by laboratory values. 13. QT interval corrected with the Fridericia formula (QTcF) ≤ 480 milliseconds in 12-lead electrocardiogram (ECG) at Screening.	1. Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (\> 10 mg of prednisone equivalent per day), immunosuppressive agents, or disease-modifying agents. 2. Presence or history of interstitial lung disease and (non-infectious) pneumonitis that required corticosteroids. 3. Active clinically significant bacterial, viral or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before the first dose of study intervention. 4. Uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association (NYHA) classification III or IV. 5. A positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibody (a confirmatory HCV RNA test if HCV antibody was positive). 6. A positive serological test for human immunodeficiency virus (HIV) infection. 7. Known history of any other relevant congenital or acquired immunodeficiency. 8. Known history of an allogeneic tissue and/or solid organ transplant. 9. Known history of severe allergy, hypersensitivity, anaphylaxis, or any serious adverse reaction to any component of study intervention or formulation components and/or any other monoclonal antibodies. 10. Women who are pregnant or breastfeeding or trying to become pregnant. 11. Clinical evidence of uncontrolled brain metastasis. 12. Known additional malignancy that is progressing or has required active treatment within the past 3 years. 13. (Parts A-2 and C only): Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137), and was discontinued from that treatment due to ≥ Grade 3 immune-related adverse event (irAE). 14. Prior treatment with systemic anticancer drugs (including any investigational medicinal products) within 28 days or 5 half-lives (whichever is shorter) before the first dose of study intervention. 15. Prior major surgery within 28 days before the first dose of study intervention. 16. Prior extended field radiotherapy within 28 days before the first dose of study intervention (within 14 days for limited field radiation for palliation) or history of radiation pneumonitis. 17. Participants who have not recovered from any previous treatment toxicities to ≤ Grade 1 or baseline (except alopecia and peripheral neuropathy) before the first dose of study intervention. 18. Prior treatment with anti-CCR8 antibody for any indication. 19. Receipt of hematopoietic growth factors (eg, granulocyte-colony stimulating factor \[G-CSF\] or erythropoietin) within 14 days before the first dose of study intervention or blood transfusions within 14 days before the first dose of study intervention. 20. Receipt of a live, attenuated vaccine within 30 days before the first dose of study intervention.

Inclusion Criteria

Exclusion Criteria

1. Male or female participant must be at least 18 years of age inclusive (or complies with country-specific regulatory requirements), at the time of signing the informed consent.
2. Participants with histologically or cytologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical benefit, or who are intolerant to or unwilling to receive these therapies for any reasons.
3. Measurable disease by RECIST 1.1.
4. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma (UC), non-small cell lung cancer (NSCLC), or triple-negative breast cancer (TNBC), esophageal cancer (EC; esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (GC; gastric and gastroesophageal junction adenocarcinoma).
5. (Part B only) Participants should have 1 of specific histologically or cytologically confirmed tumor types selected by the sponsor after the determination of tentative RP2D(s) in Part A-1.
6. (Part C only) Participants should have 1 of specific histologically or cytologically confirmed tumor types selected by the sponsor after the determination of tentative RP2D(s) in Part A-2.
7. Participants should be willing and able to provide permission to access archival formalin-fixed paraffin-embedded (FFPE) tumor tissues (as block or unstained slides) for this study.
8. Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples.
9. (At selected sites only) Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples. Fresh tissue samples are required as these will be used for the proof of mechanism analysis.
10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
11. An estimated life expectancy of at least 12 weeks.
12. Adequate hematologic and organ function as confirmed by laboratory values.
13. QT interval corrected with the Fridericia formula (QTcF) ≤ 480 milliseconds in 12-lead electrocardiogram (ECG) at Screening.

1. Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (\> 10 mg of prednisone equivalent per day), immunosuppressive agents, or disease-modifying agents.
2. Presence or history of interstitial lung disease and (non-infectious) pneumonitis that required corticosteroids.
3. Active clinically significant bacterial, viral or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before the first dose of study intervention.
4. Uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association (NYHA) classification III or IV.
5. A positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibody (a confirmatory HCV RNA test if HCV antibody was positive).
6. A positive serological test for human immunodeficiency virus (HIV) infection.
7. Known history of any other relevant congenital or acquired immunodeficiency.
8. Known history of an allogeneic tissue and/or solid organ transplant.
9. Known history of severe allergy, hypersensitivity, anaphylaxis, or any serious adverse reaction to any component of study intervention or formulation components and/or any other monoclonal antibodies.
10. Women who are pregnant or breastfeeding or trying to become pregnant.
11. Clinical evidence of uncontrolled brain metastasis.
12. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
13. (Parts A-2 and C only): Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137), and was discontinued from that treatment due to ≥ Grade 3 immune-related adverse event (irAE).
14. Prior treatment with systemic anticancer drugs (including any investigational medicinal products) within 28 days or 5 half-lives (whichever is shorter) before the first dose of study intervention.
15. Prior major surgery within 28 days before the first dose of study intervention.
16. Prior extended field radiotherapy within 28 days before the first dose of study intervention (within 14 days for limited field radiation for palliation) or history of radiation pneumonitis.
17. Participants who have not recovered from any previous treatment toxicities to ≤ Grade 1 or baseline (except alopecia and peripheral neuropathy) before the first dose of study intervention.
18. Prior treatment with anti-CCR8 antibody for any indication.
19. Receipt of hematopoietic growth factors (eg, granulocyte-colony stimulating factor \[G-CSF\] or erythropoietin) within 14 days before the first dose of study intervention or blood transfusions within 14 days before the first dose of study intervention.
20. Receipt of a live, attenuated vaccine within 30 days before the first dose of study intervention.

Contacts and Locations

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

800-849-9707

Shionogiclintrials-admin@shionogi.co.jp

Principal Investigator

Shionogi Clinical Trials Administrator Clinical Support Help Line

STUDY_DIRECTOR

Shionogi

Study Locations (Sites)

Angeles Clinic and Research Center

Los Angeles, California, 90025

United States

Henry Ford Health Center

Detroit, Michigan, 48202

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Shionogi

Shionogi Clinical Trials Administrator Clinical Support Help Line, STUDY_DIRECTOR, Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-30

Study Completion Date2027-04-16

Study Record Updates

Study Start Date2022-05-30

Study Completion Date2027-04-16

Terms related to this study

Keywords Provided by Researchers

C-C motif chemokine receptor 8 (CCR8)

Additional Relevant MeSH Terms

Solid Tumors