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 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.
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
590 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 months4
PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)
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