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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation — Cycle 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
Trial sites (9)
Facility
City
Region
Status
Honor Health Research Institute
Scottsdale
Arizona
Not Yet Recruiting
Macquarie University Clinical Trial Unit
North Ryde
New South Wales
Recruiting
Cancer Research SA
Adelaide
South Australia
Recruiting
Peninsula & South Eastern Haematology & Oncology Group
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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