Trial Title:
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
NCT ID:
NCT05875168
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
DS-3939a
anti-body drug conjugate
advanced/metastatic solid tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DS-3939a
Description:
One IV infusion Q3W on Day 1 of each 21-day cycle
Arm group label:
Dose Escalation (Part 1)
Arm group label:
Dose Expansion (Part 2)
Summary:
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in
participants with advanced solid tumors.
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).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
University of Texas M.D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The Medical College of Wisconsin, INC
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Not yet recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
See Central Contact
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
See Central Contact
Facility:
Name:
Cancer Institute Hospital of Jfcr
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitari Vall D'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Next Madrid
Address:
City:
Pozuelo de Alarcón
Zip:
28223
Country:
Spain
Status:
Not yet recruiting
Start date:
August 18, 2023
Completion date:
July 11, 2027
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05875168
