Informations générales (source: ClinicalTrials.gov)
A Phase 1/2, Multicentre, Open-label Clinical Trial of DT-7012 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Selected Advanced Solid Tumors (DOMISOL, DOmain_therapeutics Monoclonal antIbody for SOLid Tumors)
Interventional
Phase 1/Phase 2
Domain Therapeutics Australia Pty Ltd (Voir sur ClinicalTrials)
juin 2025
janvier 2028
07 mai 2026
This is a phase 1/2, dose-escalation, clinical study to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8
monoclonal antibody) as a single agent and in combination with an immune checkpoint
inhibitor in adult participants with selected 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 | Antoine ITALIANO | 04/05/2026 14:45:05 | Contacter | ||
Critères
Tous
- Histologically or cytologically confirmed solid tumor, among selected cancer types,
that is recurrent, locally advanced (i.e., not eligible for curative surgery or
radiotherapy) or metastatic, has progressed after at least one line of systemic
therapy and has no established curative option.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as
assessed by the local site investigator/radiologist.
- At least 1 tumour lesion accessible to biopsy per treating physician judgement.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Any unresolved AEs from previous anti-cancer therapies of grade ≥2, with the
exception of alopecia.
- Prior severe immune-related AEs (irAEs) leading to immunotherapy treatment
discontinuation.
- Major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1
with unadequately recovered AEs and/or complications from the intervention prior to
Cycle 1 Day 1.
- Prior radiotherapy within the 4 weeks prior to Cycle 1 Day 1 or limited field
palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1.
- Prior anti-CCR8 monoclonal antibody treatment received in an investigational trial