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

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)

This study tests whether DT-7012, given alone or with an immune checkpoint blocker, is safe and can help adults with selected advanced solid tumors that have progressed after prior treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Domain Therapeutics SA (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 9 sites (Scottsdale, Arizona and 8 other locations)
• Trial ID: NCT06819735 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed selected recurrent or metastatic solid tumors that progressed after at least one systemic therapy, with measurable disease, at least one lesion accessible for biopsy, ECOG 0–1, and adequate organ function.

Not a fit: Patients with unresolved grade ≥2 adverse events from prior cancer therapy, prior severe immune-related adverse events leading to immunotherapy discontinuation, recent major surgery without recovery, or poor performance status are less likely to benefit or be eligible.

Why it matters

Potential benefit: If successful, DT-7012 could provide a new option that enhances anti-tumor immune responses and improves outcomes for some patients with advanced solid tumors, especially when used with checkpoint inhibitors.

How similar studies have performed: Targeting CCR8 to deplete tumor regulatory T cells is a relatively new approach with promising preclinical data and limited early clinical evidence suggesting potential synergy with checkpoint inhibitors but no broad clinical confirmation yet.

Eligibility criteria

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 this trial is running

Scottsdale, Arizona and 8 other locations

• Honor Health Research Institute — Scottsdale, Arizona, United States (Not_yet_recruiting)
• 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)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)

Study contacts

• Study coordinator: Clinical Development

Conditions Advanced Solid Tumors