DT-7012 alone and with an immune checkpoint blocker for adults with selected advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label phase 1/2 trial will enroll adults with selected recurrent, locally advanced, or metastatic solid tumors to study DT-7012 as monotherapy and combined with an immune checkpoint inhibitor. Phase 1 includes dose-escalation for monotherapy and a subsequent combination dose-escalation to determine the maximum tolerated or administered dose and characterize safety, pharmacokinetics, and pharmacodynamics. After dose selection, phase 2 will open indication-specific cohorts to measure preliminary efficacy signals using standard response criteria. The study requires measurable disease, at least one lesion suitable for biopsy, and an ECOG performance status of 0–1.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Where it's running

• Macquarie University Clinical Trial Unit
  North Ryde, New South Wales, Australia Recruiting
• Cancer Research SA
  Adelaide, South Australia, Australia Recruiting
• Peninsula & South Eastern Haematology & Oncology Group
  Frankston, Victoria, Australia Recruiting
• Cabrini Health Limited
  Malvern, Victoria, Australia Recruiting
• One Clinical Research Pty Ltd
  Nedlands, Western Australia, Australia Recruiting
• Institut Bergonié
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Clinical Development
• Email: clinicaltrials@domaintherapeutics.com
• Phone: 0033390406150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.