Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT06819735
- Run by
- Domain Therapeutics Australia Pty Ltd
- People needed
- 125
- Starts
- 2025-06-25
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Macquarie University Clinical Trial Unit — North Ryde, New South Wales, Australia (enrolling)
- Cancer Research SA — Adelaide, South Australia, Australia (enrolling)
- Peninsula & South Eastern Haematology & Oncology Group — Frankston, Victoria, Australia (enrolling)
- Cabrini Health Limited — Malvern, Victoria, Australia (enrolling)
- One Clinical Research Pty Ltd — Nedlands, Western Australia, Australia (enrolling)
- Institut Bergonié — Bordeaux, France (enrolling)
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (enrolling)
- Honor Health Research Institute — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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