Informations générales (source: ClinicalTrials.gov)
Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Interventional
Phase 1/Phase 2
Daiichi Sankyo (Voir sur ClinicalTrials)
août 2023
février 2027
02 septembre 2026
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in
participants with advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 01/09/2026 20:10:03 | Contacter | ||
Critères
Tous
- 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.