Actively Recruiting
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
Led by Shionogi · Updated on 2026-03-18
282
Participants Needed
8
Research Sites
313 weeks
Total Duration
On this page
Sponsors
S
Shionogi
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with confirmed advanced or metastatic solid tumors with no effective standard therapies or unable/unwilling to receive them
- Measurable disease using Response Evaluation Criteria in Solid Tumors version 1.1
- For Part A, have one of the specified tumor types including melanoma, head and neck cancer, renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, esophageal or gastric cancer; other tumors may be included with sponsor approval
- For Parts B, C, D, E (colorectal cancer cohorts), have confirmed metastatic adenocarcinoma of colon or rectum with disease progression after standard therapies or intolerance, including specific chemotherapy and targeted therapies
- Willing and able to provide archival tumor tissue and paired tumor biopsies before and during treatment
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood and organ function as shown by lab tests
- QT interval corrected with Fridericia formula 480 milliseconds or less on ECG at screening
You will not qualify if you...
- History or presence of autoimmune or immune-mediated diseases requiring chronic corticosteroids or immunosuppressants
- History of interstitial lung disease or pneumonitis needing corticosteroids
- Active significant infections or recent major infections requiring hospitalization or intravenous treatments within 4 weeks before treatment
- Uncontrolled or serious heart disease (NYHA class III or IV)
- Positive hepatitis B surface antigen or hepatitis C antibody with detectable RNA
- Positive HIV test or known immunodeficiency
- History of organ or tissue transplant
- Severe allergy or serious reaction to study drugs or similar antibodies
- Pregnant, breastfeeding, or trying to become pregnant
- For Parts D and E, non-healing wounds, ulcers, or bone fractures
- For Parts D and E, recent serious arterial or venous thromboembolic events or bleeding disorders
- For Parts D and E, history of severe VEGF-related adverse events or proteinuria 2+ or higher
- Uncontrolled brain metastases or symptomatic pleural effusion/ascites requiring drainage
- Other active cancers needing treatment within past 3 years
- Colorectal cancer with mismatch repair deficiency or microsatellite instability-high status (Parts B, C, D, E)
- Prior severe immune-related adverse events from checkpoint inhibitors (Parts A-2, C, E)
- Recent systemic anticancer therapy, major surgery, or extensive radiotherapy within 28 days before treatment
- Unresolved prior treatment toxicities above Grade 1 except hair loss or neuropathy
- Prior treatment with anti-CCR8 antibody
- Recent use of hematopoietic growth factors or blood transfusions
- Allergies or hypersensitivity to bevacizumab or related products (Parts D and E)
- Receipt of live attenuated vaccines within 30 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Angeles Clinic and Research Center
Los Angeles, California, United States, 90025
Active, Not Recruiting
2
University of Florida Health
Gainesville, Florida, United States, 32610
Actively Recruiting
3
Henry Ford Health Center
Detroit, Michigan, United States, 48202
Active, Not Recruiting
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Actively Recruiting
7
The University of Osaka Hospital
Suita, Osaka, Japan
Actively Recruiting
8
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Actively Recruiting
Research Team
S
Shionogi Clinical Trials Administrator Clinical Support Help Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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