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

Purpose

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

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Is able to provide either of the following baseline tumor samples: 1. 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 - Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual. 2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.

Exclusion Criteria

  • Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. - Has spinal cord compression or 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 any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. - 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 (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease. - Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation (Part 1) 		Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a starting at 1 mg/kg.
  • Drug: DS-3939a
    One IV infusion Q3W on Day 1 of each 21-day cycle
Experimental
Dose Expansion (Part 2) 		Multiple expansion cohorts targeting various advanced solid tumors.
  • Drug: DS-3939a
    One IV infusion Q3W on Day 1 of each 21-day cycle

Recruiting Locations

University of Kansas Medical Center
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
Daiichi Sankyo

Study Contact

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
908-992-6400
CTRinfo@dsi.com

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).