RECRUITING

A Study of DS5361b in Participants With Advanced Solid Tumors

Conditions

Advanced Solid Tumor First-in-Human Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS5361b in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2025-09-10

Study Completion:2030-12-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07182591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 5. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention. 6. 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. 7. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration. 8. No prior systemic therapy. 9. Participants with PD-L1 TPS ≥1%. 10. Participants with PD-L1 positive defined by CPS ≥1. 11. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.	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.

Inclusion Criteria

Exclusion Criteria

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. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
5. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.
6. 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.
7. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.
8. No prior systemic therapy.
9. Participants with PD-L1 TPS ≥1%.
10. Participants with PD-L1 positive defined by CPS ≥1.
11. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.

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.

Contacts and Locations

Study Contact

Contact for Trial Information

CONTACT

908-992-6400

CTRinfo_us@daiichisankyo.com

Study Locations (Sites)

Research Site

Irving, Texas, 75039

United States

Research Site

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-10

Study Completion Date2030-12-03

Study Record Updates

Study Start Date2025-09-10

Study Completion Date2030-12-03

Terms related to this study

Keywords Provided by Researchers

First-in-Human
Advanced Solid Tumors

Additional Relevant MeSH Terms

Advanced Solid Tumor