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RECRUITINGPHASE1/PHASE2

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

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

NCT05101070•Shionogi

View on ClinicalTrials.gov

Summary

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 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab. The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1.
•3. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, or triple-negative breast cancer, esophageal cancer (esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (gastric and gastroesophageal junction adenocarcinoma). Participants with colorectal cancer (CRC), pancreatic cancer, cervical cancer, epithelial ovarian cancer, and other types of solid tumors may also be enrolled upon discussion with and approval by the sponsor. For the backﬁll cohorts only, speciﬁc tumor types may be selected.
•4. (Part B CRC cohorts only) Participants must have histologically or cytologically conﬁrmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: ﬂuoropyrimidine, oxaliplatin, and irinotecan; anti-epidermal growth factor receptor (EGFR) therapy if rat sarcoma virus (RAS) (Kirsten RAS/neuroblastoma RAS \[KRAS/NRAS\]) wild-type and medically appropriate ; V-raf murine sarcoma viral oncogene homolog B (BRAF) inhibitor if BRAF V600E mutation. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: triﬂuridine/tipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.
•5. (Part C CRC cohorts only) Participants must have histologically or cytologically conﬁrmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: ﬂuoropyrimidine, oxaliplatin, and irinotecan; anti-EGFR therapy if RAS (KRAS/NRAS) wild-type and medically appropriate ; BRAF inhibitor if BRAF V600E mutation. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: triﬂuridine/tipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.
•6. (Parts D and E) Participants must have histologically or cytologically conﬁrmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: fluoropyrimidine, oxaliplatin, and irinotecan; anti-EGFR therapy if RAS (KRAS/NRAS) wild-type and medically appropriate; BRAF inhibitor if BRAF-V600E mutation.. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: triﬂuridine/tipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.
•7. Participants should be willing and able to provide permission to access archival formalin-ﬁxed paraffin-embedded 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. (Part A and B/CRC Cohorts only; 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 (ﬂow cytometry) analysis.
•10. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
+27 more criteria

Exclusion Criteria

•1. Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (\> 10 milligrams 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 classiﬁcation III or IV.

Locations (8)

Angeles Clinic and Research Center

Los Angeles, California, United States

University of Florida Health

Gainesville, Florida, United States

Henry Ford Health Center

Detroit, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Key Dates

Start Date

May 30, 2022

Primary Completion Date

May 31, 2028

Completion Date

May 31, 2028

Last Updated

March 18, 2026

Enrollment

282

ESTIMATED participants

Conditions

Solid Tumors

Interventions

S-531011

DRUG

Pembrolizumab

DRUG

Bevacizumab

DRUG

Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

800-849-9707 Shionogiclintrials-admin@shionogi.co.jp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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