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RecruitingLast updated: 18 September 2025

DOMISOL: This study is recruiting people with advanced solid cancers to evaluate a new immunotherapy drug (called DT-7012) by itself and in combination with other immunotherapy treatmentsA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

DOMISOL

Clinical summary

Summary

This study is recruiting people with certain recurrent, advanced or metastatic solid cancers to assess how safe and effective a new immunotherapy called DT-7012 is when given by itself (monotherapy) and in combination with an immune checkpoint inhibitor. DT-7012 is a monoclonal antibody, that targets and binds to CCR8 receptors to improve the anti-tumour immune response.

The study has two parts.

Part 1 has two arms: dose escalation of DT-7012 given as monotherapy, and dose escalation of DT-7012 given in combination with an immune checkpoint inhibitor.

Part 2 will further evaluate DT-7012 as monotherapy and/or in combination with an immune checkpoint inhibitor in expansion cohorts of 2-3 specific cancer types.

All treatments will be given as intravenous infusions.

Eligible tumour types include: non-small cell lung cancer, triple neative breast cancer, HR+ breast cancer, ovarian cancer, cervicacl squamous cell carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, stomach cancer, oesophageal cancer, liver cancer, pancreatic cancer or bowel cancer (colorecal).

 

Conditions

This trial is treating people with recurrent, locally advanced or metastatic solid cancers that have progressed on at least one prior line of treatment and have no established curative option

Eligibility

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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Domain Therapeutics Australia Pty Ltd

Scientific Title

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)

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