RECRUITING

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Conditions

Advanced Solid Tumor Metastatic Solid Tumor DS-3939a anti-body drug conjugate advanced/metastatic 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 will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Official Title

Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors

Quick Facts

Study Start:2023-08-18

Study Completion:2027-07-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05875168

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
* Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes. * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy. * Is able to provide either of the following baseline tumor samples: * Fresh core needle biopsy samples obtained during the Screening Period, or * Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF	* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. * Has spinal cord compression or history of/clinically active central nervous system metastases. * Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years. * Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. * Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count. * Has evidence of active hepatitis B virus or hepatitis C virus infection. * Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. * Has an active, known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Inclusion Criteria

Exclusion Criteria

* Sign and date the main Informed Consent Form (ICF).
* Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
* Has adequate organ function.
* Measurable disease based on RECIST V1.1.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.
* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
* Is able to provide either of the following baseline tumor samples:
* Fresh core needle biopsy samples obtained during the Screening Period, or
* Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF

* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
* Has spinal cord compression or history of/clinically active central nervous system metastases.
* Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
* Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
* Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count.
* Has evidence of active hepatitis B virus or hepatitis C virus infection.
* Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
* Has an active, known, or suspected autoimmune disease.
* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Contacts and Locations

Study Contact

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400

CTRinfo@dsi.com

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

+81-3-6225-1111 (M-F 9-5 JST)

dsclinicaltrial@daiichisankyo.co.jp

Principal Investigator

Global Clinical Leader

STUDY_DIRECTOR

Daiichi Sankyo

Study Locations (Sites)

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

United States

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Global Clinical Leader, STUDY_DIRECTOR, 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 Date2023-08-18

Study Completion Date2027-07-11

Study Record Updates

Study Start Date2023-08-18

Study Completion Date2027-07-11

Terms related to this study

Keywords Provided by Researchers

DS-3939a
anti-body drug conjugate
advanced/metastatic solid tumors

Additional Relevant MeSH Terms

Advanced Solid Tumor
Metastatic Solid Tumor