Actively Recruiting
A Study of DS5361b in Participants With Advanced Solid Tumors
Led by Daiichi Sankyo · Updated on 2026-05-14
192
Participants Needed
7
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study of DS5361b in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of consent
- Histologically or cytologically confirmed recurrent, metastatic, or unresectable solid tumors that are refractory or intolerable to standard treatments or have no standard treatment available (Parts 1 and 2)
- Documented tumor mutational burden-high (TMB-H) and/or microsatellite instability-high (MSI-H) status prior to treatment (Parts 1 and 2 require TMB-H and/or MSI-H; Part 3 requires TMB-H)
- Measurable disease based on local CT or MRI imaging assessed by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ and bone marrow function based on local laboratory tests within 14 days before starting treatment
- For head and neck squamous cell carcinoma (HNSCC) participants: documented HPV testing results for oropharyngeal cancer
- For dose expansion (Part 3) only: confirmed Stage IV non-small cell lung cancer (NSCLC) without actionable gene alterations, no prior systemic therapy, and PD-L1 tumor proportion score (TPS) of 1% or higher
- For dose expansion (Part 3) only: confirmed recurrent or metastatic HNSCC considered incurable by local therapies, no prior systemic therapy in the recurrent or metastatic setting, and PD-L1 combined positive score (CPS) of 1 or higher
You will not qualify if you...
- Spinal cord compression or active central nervous system metastases
- History of leptomeningeal carcinomatosis
- Uncontrolled or significant cardiovascular disease
- Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event within 6 months prior to enrollment
- History of noninfectious interstitial lung disease (ILD) or pneumonitis requiring corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out
- Severe pulmonary compromise requiring supplemental oxygen
- Severe or uncontrolled systemic diseases
- Active or uncontrolled hepatitis B infection
- Active or uncontrolled hepatitis C infection
- HIV infection for dose escalation phases (Parts 1 and 2) or active/uncontrolled HIV infection for dose expansion (Part 3)
- Prior organ transplantation including allogeneic stem cell transplantation
- Active, known, or suspected autoimmune disease
- Diagnosis of immunodeficiency or receiving systemic steroids or other immunosuppressive therapy within 14 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Research Site
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
3
Research Site
Irving, Texas, United States, 75039
Actively Recruiting
4
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
5
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
7
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here