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New treatment option for Advanced Solid Tumor
Official title A Study of DS5361b in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07182591
What this study is testing
What is DS5361b?
DS5361b is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key The clinical site will screen for the full per protocol.
- Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial...
- Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with...
- Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day...
- Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
You likely can't join if
- Has spinal cord compression or clinically active central nervous system metastases.
- Has a history of leptomeningeal carcinomatosis.
- Uncontrolled or significant cardiovascular disease.
- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial...
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where...
- Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).
See the full eligibility criteria
- Key The clinical site will screen for the full per protocol.
- Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old).
- Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part...
- Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H...
- Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.
- For HNSCC participants only: have documented results from local testing of HPV for oropharyngeal cancer. If HPV status has previously been tested using this procedure, no retesting is required. Dose Expansion (Part 3)...
- Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.
- No prior systemic therapy.
- Participants with PD-L1 TPS ≥1%.
- Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
- No prior systemic therapy administered in the recurrent or metastatic setting.
- Participants with PD-L1 CPS ≥1. Key
- Has spinal cord compression or clinically active central nervous system metastases.
- Has a history of leptomeningeal carcinomatosis.
- Uncontrolled or significant cardiovascular disease.
- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out.
- Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).
- Has any evidence of severe or uncontrolled systemic diseases.
- Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required.
- Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required.
- For the dose escalation phase (Part 1 and Part 2), has HIV infection. For the dose expansion part (Part 3), has active or uncontrolled HIV infection.
- Prior organ transplantation, including allogeneic stem cell transplantation.
- Has an active, known, or suspected autoimmune disease.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Providence, Rhode Island, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Kashiwa, Japan
- Kōtoku, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Providence, Rhode Island, United States; Irving, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States; Kashiwa, Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.