Advanced Solid TumorsPhase 1/2DOMISOLNCT06819735
Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors
A Phase 1/2 study testing DT-7012 and Immune checkpoint inhibitor in people with Advanced Solid Tumors, run by Domain Therapeutics Australia Pty Ltd at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- DT-7012 and Immune checkpoint inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 25 Jun 2025to Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
Australia5 sites, 5 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
- Recruiting
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
- Recruiting
Cabrini Health Limited
Malvern, Victoria, 3144
- Recruiting
One Clinical Research Pty Ltd
Nedlands, Western Australia, 6009
- Recruiting
Macquarie University Clinical Trial Unit
North Ryde, New South Wales, 2109
France3 sites, 3 recruiting
- Recruiting
Institut Bergonié
Bordeaux, 33076
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
United States1 site, 1 recruiting
- Not yet recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
About this study
Official 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)
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.
Read the detailed description
This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.
This study includes:
- a phase 1 Monotherapy Dose Escalation
- a phase 1b Combination Dose Escalation (this part will be initiated upon recommendation from the Safety Review Committee based on Monotherapy Dose Escalation data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)
- a subsequent phase 2 Indication-Specific Efficacy part
The phase 1 aims at determining the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI, and the safety and tolerability of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.
The phase 2 will assess the efficacy of DT-7012 as monotherapy and/or in combination with an ICI in indication-specific cohorts.
- Conditions
- Advanced Solid Tumors
- Being tested
- DT-7012, Immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-7012Drug
Intravenous infusion
Immune checkpoint inhibitorDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1A | Experimental | Dose escalation of DT-7012 as a single agent Receives: Drug: DT-7012 |
| Part 1B | Experimental | Dose escalation of DT-7012 in combination with an ICI Receives: Drug: DT-7012; Drug: Immune checkpoint inhibitor |
| Phase 2 | Experimental | Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts. Receives: Drug: DT-7012; Drug: Immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation
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
Measured: Cycle 1 (21 days)
Secondary outcomes (2)
Objective response rate (ORR)
The anti-tumor activity will be determined based on the assessment of, but not limited to, the objective response rate (ORR). ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) at any time during the study according to RECIST v1.1 and immune RECIST (iRECIST) as assessed by the investigator.
Measured: From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months
Serum concentrations of DT-7012
Serum concentrations of DT-7012 will be determined to evaluate the pharmacokinetics (PK) of DT-7012
Measured: From the first dose of study drug until the date of end of treatment, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start25 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Domain Therapeutics Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Domain Therapeutics SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819735
- Sponsor's protocol ID
- DT-7012-CLI-001
- Acronym
- DOMISOL
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06819735
- Acronym / sponsor ID
- DOMISOL / DT-7012-CLI-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Domain Therapeutics Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Domain Therapeutics SA
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.
This study includes:
- a phase 1 Monotherapy Dose Escalation
- a phase 1b Combination Dose Escalation (this part will be initiated upon recommendation from the Safety Review Committee based on Monotherapy Dose Escalation data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)
- a subsequent phase 2 Indication-Specific Efficacy part
The phase 1 aims at determining the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI, and the safety and tolerability of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.
The phase 2 will assess the efficacy of DT-7012 as monotherapy and/or in combination with an ICI in indication-specific cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1A | Experimental | Drug: DT-7012Dose escalation of DT-7012 as a single agent |
| Part 1B | Experimental | Drug: DT-7012, Drug: Immune checkpoint inhibitorDose escalation of DT-7012 in combination with an ICI |
| Phase 2 | Experimental | Drug: DT-7012, Drug: Immune checkpoint inhibitorEvaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT-7012Intravenous infusion | Drug | Part 1A, Part 1B, Phase 2 |
| Immune checkpoint inhibitorIntravenous infusion | Drug | Part 1B, Phase 2 |
Primary outcome
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation
Time frame: 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
2 secondary outcomes
Objective response rate (ORR)
Time frame: From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months
Serum concentrations of DT-7012
Time frame: From the first dose of study drug until the date of end of treatment, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DT-7012 and Immune checkpoint inhibitor in people with Advanced Solid Tumors, run by Domain Therapeutics Australia Pty Ltd at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development (0033390406150, clinicaltrials@domaintherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation (time frame: Cycle 1 (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.