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Study of DT-7012 for Advanced Solid Tumors

This study is testing a new treatment called DT-7012, given alone or with another type of cancer drug called an immune checkpoint inhibitor. DT-7012 is a monoclonal antibody, which is a type of immunotherapy. This study is for adults (18 and older) with advanced solid tumors that have not responded to previous treatments and for which there are no other curative options. To join, your tumor must be measurable. The main goal is to see how safe DT-7012 is and what side effects it might cause, especially in the first 21 days of treatment. Researchers will also look at how well the treatment works. This study is currently recruiting participants.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve approximately 125 participants and will first look at different doses of DT-7012 alone, then in combination with an immune checkpoint inhibitor.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints are measured at Cycle 1 (21 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06819735

Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Domain Therapeutics Australia Pty Ltd
~125 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:DT-7012Immune checkpoint inhibitor

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation
Measured over Cycle 1 (21 days)

Conditions

Advanced Solid Tumors

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NCT06819735

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cabrini Health Limited

    Malvern, Victoria, Australiano site contact published

    Recruiting

  • Cancer Research SA

    Adelaide, South Australia, Australiano site contact published

    Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizonano site contact published

    Not yet recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, Franceno site contact published

    Recruiting

  • Institut Bergonié

    Bordeaux, Franceno site contact published

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Franceno site contact published

    Recruiting

  • Macquarie University Clinical Trial Unit

    North Ryde, New South Wales, Australiano site contact published

    Recruiting

  • One Clinical Research Pty Ltd

    Nedlands, Western Australia, Australiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clinical Development
[email protected]
0033390406150
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuationCycle 1 (21 days)

    Proportion of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and adverse events (AEs) leading to treatment discontinuation