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NCT05875168 | Recruiting | Advanced Solid Tumor

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

1st Sankyo

Brief Summary:

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Condition or disease

Advanced Solid Tumor

Metastatic Solid Tumor

Intervention/treatment

Stick a stick

Phase

Phase 1

Phase 2

Detailed Description:

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).}}

Study Type : Interventional
Estimated Enrollment : 430 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Actual Study Start Date : August 18, 2023
Estimated Primary Completion Date : March 17, 2026
Estimated Study Completion Date : July 11, 2027
Arm Intervention/treatment

Experimental: Dose Escalation (Part 1)

Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.

Drug: DS-3939a

Experimental: Dose Expansion (Part 2)

Multiple expansion cohorts targeting various advanced solid tumors.

Drug: DS-3939a
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion 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.
  • Additional inclusion criteria for Part 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.
  • Additional inclusion criteria for Part 2
  • 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
    Exclusion Criteria
    • 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.
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Florida

Florida Cancer Specialists

Sarasota, florida, United States, 34232

Not yet recruiting

United States, North Carolina

Novant Health Clinical Research, LLC

Charlotte, North Carolina, United States, 28204

Recruiting

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Recruiting

United States, Utah

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

Recruiting

Japan,

National Cancer Center Hospital East

Chiba, Japan, 277-8577

Recruiting

Japan,

National Cancer Center Hospital

Tokyo, Japan, 104-0045