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First -in-Human Study of DS-3939a in Subjects with Advanced Solid Tumors
EU CTIS ID: 2023-507937-14-00
What this study is testing
Part 1: Evaluate the safety and tolerability of DS-3939a Part 2: Evaluate the safety and tolerability of DS-3939a at Recommended Dose for Expansion (RDE(s)) Evaluate Objective Response Rate (ORR) of subjects treated with DS-3939a
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 malignat tumors.
You likely can't join if
- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- Has spinal cord compression or clinically active CNS 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 active or uncontrolled hepatitis B virus or hepatitis C virus infection.
See the full eligibility 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 malignat 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.
- Additional inclusion criteria for Part 2: Is able to provide either of the following baseline tumor samples: a. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Screening Period, or o Fresh core needle biopsy sample o Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy b. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the 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.
- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- Has spinal cord compression or clinically active CNS 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- China
- Japan
- United States
- Korea, Democratic People's Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; China; Japan; United States; Korea, Democratic People's Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.