NCT06819735 Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors
| NCT ID | NCT06819735 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Domain Therapeutics Australia Pty Ltd |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 125 participants in total. It began in 2025-06-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06819735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06819735 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06819735 currently recruiting?
Yes, NCT06819735 is actively recruiting participants. Contact the research team at clinicaltrials@domaintherapeutics.com for enrollment information.
Where is the NCT06819735 trial being conducted?
This trial is being conducted at Scottsdale, United States, North Ryde, Australia, Adelaide, Australia, Frankston, Australia and 5 additional locations.
Who is sponsoring the NCT06819735 clinical trial?
NCT06819735 is sponsored by Domain Therapeutics Australia Pty Ltd. The trial plans to enroll 125 participants.