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NCT05875168 | RECRUITING | Advanced Solid Tumor

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

First mountain

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

DS-3939a

Phase

PHASE1

PHASE2

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 : 470 participants
Masking : NONE
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 : 2023-08-18
Estimated Primary Completion Date : 2026-03-17
Estimated Study Completion Date : 2027-07-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 solid malignant tumors.
  • 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 tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or
    • * Fresh core needle biopsy sample
    • * Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
    • * 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 non-melanoma 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 or uncontrolled human immunodeficiency virus (HIV) infection.
    • * Has evidence of active or uncontrolled 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

NCT05875168

Please Choose a site

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, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

NOT YET RECRUITING

United States, Texas

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

NOT YET RECRUITING

United States, Wisconsin

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin, United States, 53226

NOT YET RECRUITING

Belgium,

UZ Leuven

Leuven, Belgium, 3000

NOT YET RECRUITING

France,

Center Léon Bérard

Lyon, France, 69008

NOT YET RECRUITING

France,

Institut Claudius Regaud

Toulouse, France, 31059

NOT YET RECRUITING

France,

Gustave Roussy Institute

Villejuif cedex, France, 94805

RECRUITING

Japan,

National Cancer Center Hospital

C-Cry, Japan, 104-0045

RECRUITING

Japan,

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

NOT YET RECRUITING

Japan,

Cancer Institute Hospital of Jfcr

Small talk, Japan, 135-8550

NOT YET RECRUITING

Japan,

Kindai University Hospital

Osaka-Sayama, Japan, 589-8511

NOT YET RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

NOT YET RECRUITING

Korea, Republic of,

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

NOT YET RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of, 05505

NOT YET RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of, 06351

NOT YET RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 8035

NOT YET RECRUITING

Spain,

Next Madrid

Pozuelo de Alarcón, Spain, 28223