First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Sequential
Treatments tested in this trial
DS-3939a
DrugOne IV infusion Q3W on Day 1 of each 21-day cycle
Treatment groups
540 Participants
are divided into 2 treatment groupsGroup A: Dose Escalation (Part 1)Experimental treatment 1 intervention
Group B: Dose Expansion (Part 2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a
Time frame
Approximately 3 months after first dosing2
Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
Time frame
Up to approximately 31 months3
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)
Time frame
Up to approximately 31 monthsSecondary outcomes
1
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)
Time frame
Up to approximately 31 months2
Disease Control Rate Following Treatment With DS-3939a
Time frame
Up to approximately 31 months3
Duration of Response Following Treatment With DS-3939a
Time frame
Up to approximately 31 months4
Time to Response Following Treatment With DS-3939a
Time frame
Up to approximately 31 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov