Informations générales (source: ClinicalTrials.gov)
A Phase 1, Multicentre, Open-label, Dose-escalation and Expansion Study to Determine a Recommended Phase 2 Dose (RP2D) of DT-9081 in Participants with Advanced Solid Tumours (EPRAD)
Interventional
Phase 1
Domain Therapeutics SA (Voir sur ClinicalTrials)
novembre 2022
octobre 2025
05 avril 2025
This is a Phase 1, multicentre, open-label, dose-escalation study to determine a
recommended phase 2 dose (RP2D) of DT-9081, followed by an expansion study of DT-9081 in
participants with advanced, recurrent or metastatic solid tumours
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:11 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Claudius Regaud - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants must have a histologically or cytologically confirmed advanced solid
tumour that is locally advanced (i.e., not eligible for curative surgery or
radiotherapy), recurrent or metastatic, and who have failed or are ineligible for
standard of care therapies.
- Participants must be ≥18 years of age.
- Participants must have measurable disease per RECIST v1.1. Lesions situated in a
previously irradiated area are considered measurable if progression has been
demonstrated in such lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participants must have adequate organ function.
- Participants must have a histologically or cytologically confirmed advanced solid
tumour that is locally advanced (i.e., not eligible for curative surgery or
radiotherapy), recurrent or metastatic, and who have failed or are ineligible for
standard of care therapies.
- Participants must be ≥18 years of age.
- Participants must have measurable disease per RECIST v1.1. Lesions situated in a
previously irradiated area are considered measurable if progression has been
demonstrated in such lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participants must have adequate organ function.
- Participants using drugs interfering with the COX-2 pathways or prohibited drugs.
- Participants with unresolved AEs from previous anti-cancer therapies of Grade ≥ 2
with exception of alopecia. Participants with Grade ≤ 2 neuropathy may be eligible.
- Participants who underwent major surgery or significant traumatic injury within 4
weeks prior to Cycle 1 Day 1 who have not recovered adequately from any AEs and/or
complications from the intervention prior to starting study drug.
- Participants who have received prior radiotherapy within the last 4 weeks before
start of study drug treatment (limited field palliative radiotherapy within 2
weeks).
- Participants who have already received EP4R antagonist in an investigational trial.