DS5361b alone and with pembrolizumab for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, phase 1 dose-escalation and expansion trial of DS5361b as monotherapy and in combination with the anti-PD-1 antibody pembrolizumab in adults with advanced or metastatic solid tumors. The trial will enroll biomarker-selected patients with documented TMB-H and/or MSI-H status and measurable disease, using RECIST v1.1 to monitor tumor responses. Primary objectives focus on safety, tolerability, dose-limiting toxicities, and determining the maximum tolerated dose; secondary objectives include preliminary anti-tumor activity and pharmacokinetics. Participants will undergo regular imaging and clinical assessments while receiving study treatment at designated research sites.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

The clinical site will screen for the full inclusion criteria per protocol.

1. 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).
2. 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 1 and Part 2 only).
3. 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 and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.
4. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.
7. 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) Only:
8. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.

   * No prior systemic therapy.
   * Participants with PD-L1 TPS ≥1%.
9. 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 Exclusion Criteria:

1. Has spinal cord compression or clinically active central nervous system metastases.
2. Has a history of leptomeningeal carcinomatosis.
3. Uncontrolled or significant cardiovascular disease.
4. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
5. 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.
6. Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).
7. Has any evidence of severe or uncontrolled systemic diseases.
8. Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required.
9. Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required.
10. 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.
11. Prior organ transplantation, including allogeneic stem cell transplantation.
12. Has an active, known, or suspected autoimmune disease.
13. 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.

Where it's running

• Research Site
  Sarasota, Florida, United States Recruiting
• Research Site
  Providence, Rhode Island, United States Recruiting
• Research Site
  Irving, Texas, United States Recruiting
• Research Site
  San Antonio, Texas, United States Recruiting
• Research Site
  Fairfax, Virginia, United States Recruiting
• Research Site
  Kashiwa, Japan Recruiting

Study contacts

• Study coordinator: Contact for Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.