DT-7012 + Immune Checkpoint Inhibitor for Cancer

(DOMISOL Trial)

Recruiting at 8 trial locations

Overseen By Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Domain Therapeutics Australia Pty Ltd

Disqualifiers: Unresolved AEs, Severe irAEs, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DT-7012, both alone and with an immune checkpoint inhibitor, to assess its safety and effectiveness for certain advanced solid tumors. Researchers aim to determine the optimal dose and evaluate its efficacy. Individuals with specific cancer types that have recurred or spread, and who have not responded to other treatments, might be suitable candidates. The trial targets cancers that cannot be cured with surgery or radiation. Participants should have a tumor that can be biopsied and maintain good overall organ function. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DT-7012, a new cancer treatment being tested, was generally well-tolerated in early studies with rats and monkeys, meaning it didn't cause serious side effects in these animals. However, more information from ongoing studies is needed to fully understand its safety in humans.

Regarding the immune checkpoint inhibitors used in the trial, past studies indicate that about 55.9% of patients experienced some immune-related side effects. The most common issues were hormone-related problems and skin reactions. These treatments have been widely used, and their side effects are usually manageable.

Overall, while the safety evidence is promising, more studies in humans are necessary to fully understand the effects and safety of DT-7012. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for cancer, like chemotherapy and radiation, work by targeting rapidly dividing cells, which can unfortunately harm healthy cells too. But DT-7012 is unique because it targets specific cancer pathways without affecting healthy cells, potentially reducing side effects. Researchers are excited about combining DT-7012 with immune checkpoint inhibitors because this combo could supercharge the immune system to better recognize and attack cancer cells. This approach not only offers a new mechanism of action but also holds promise for improving the effectiveness of existing therapies.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that DT-7012, a type of antibody, may help treat cancer by strongly attaching to a specific protein called CCR8. This attachment targets and reduces certain immune cells that can weaken the body's natural ability to fight cancer. Early results suggest that this could change the tumor environment and improve outcomes for patients with solid tumors. In this trial, some participants will receive DT-7012 alone, while others will receive it in combination with immune checkpoint inhibitors. Combining DT-7012 with these drugs, which help the immune system fight cancer, might enhance these effects. Other studies have demonstrated that such combination therapies can improve outcomes for patients with various types of cancer. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

My organs are working well enough for treatment.

I am fully active or can do light work despite my illness.

I have a confirmed solid tumor that has come back or spread and no cure is available.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Monotherapy Dose Escalation

Dose escalation of DT-7012 as a single agent to determine the maximum tolerated dose

Up to 12 months

Phase 1b Combination Dose Escalation

Dose escalation of DT-7012 in combination with an immune checkpoint inhibitor

Up to 12 months

Phase 2 Indication-Specific Efficacy

Evaluation of DT-7012 as a single agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DT-7012
• Immune checkpoint inhibitor

How Is the Trial Designed?

Group I: Phase 2 Experimental Treatment 2 Interventions

Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.

Group II: Part 1B Experimental Treatment 2 Interventions

Dose escalation of DT-7012 in combination with an ICI

Group III: Part 1A Experimental Treatment 1 Intervention

Dose escalation of DT-7012 as a single agent

Who Is Running the Clinical Trial?

Domain Therapeutics Australia Pty Ltd

Lead Sponsor

Trials

1

Recruited

60+

Domain Therapeutics SA

Industry Sponsor

Trials

2

Recruited

110+

Harvest Integrated Research Organization (HiRO) Australia Pty Ltd

Collaborator

Trials

1

Recruited

60+

Citations

1.

domaintherapeutics.com

domaintherapeutics.com/phase-i-ii-trial-dt-7012-targeting-ccr8-solid-tumors/

Domain Therapeutics Doses First Patients in Phase I / II ...

First patients dosed in DOMISOL trial of DT-7012, a Treg-depleting anti-CCR8 antibody, advancing immunotherapy for solid tumors.

2.

jitc.bmj.com

jitc.bmj.com/content/12/Suppl_2/A1483

1324 Characterization of DT-7012, a highly differentiated ...

Results Our results showed that DT-7012 was able to bind the human CCR8 with high affinity independently of its post-translational modification ...

3.

aacrjournals.org

aacrjournals.org/cancerres/article/86/8_Supplement/CT285/783292/Abstract-CT285-Design-and-rationale-of-DOMISOL-a

Design and rationale of DOMISOL, a first-in-human Phase I/II ...

These characteristics suggest that DT-7012 has the potential to effectively modulate the tumor microenvironment and improve clinical outcomes.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06819735

NCT06819735 | Study of DT-7012 as a Single Agent and in ...

This is a phase 1/2, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti- ...

5.

prnewswire.com

prnewswire.com/news-releases/domain-therapeutics-presents-novel-data-addressing-key-challenges-in-oncology-at-aacr-2025-302441512.html

Domain Therapeutics Presents Novel Data Addressing Key ...

The findings outline DT-9081's promising potential to inhibit tumor growth and enhance immune response in patients with advanced solid tumors.

6.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_1/312/754832/Abstract-312-Comprehensive-characterization-of-DT

Abstract 312: Comprehensive characterization of DT-7012, a ...

Preliminary safety studies confirmed the good tolerability of DT-7012 in rat and monkey. Additional data are ongoing and will be presented.

7.

domaintherapeutics.com

domaintherapeutics.com/program/dt-7012/

Anti-CCR8 depleting antibody

DT-7012, a differentiated anti-CCR8 monoclonal antibody, is a unique development in cancer immunotherapy. It has exceptional potential to preferentially deplete ...

8.

kainovatx.com

kainovatx.com/en/press-releases/kainova-therapeutics-expands-phase-i-ii-trial-of-dt-7012-a-treg-depleting-anti-ccr8-antibody-with-first-patient-dosed-in-europe/

Kainova Therapeutics Expands Phase I / II Trial of DT-7012, a ...

The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT‑7012 across both monotherapy and ...