Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors (DOMISOL)

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: DT-7012; Drug: Immune checkpoint inhibitor

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 Type: Interventional
• Enrollment (Estimated): 125
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Development; Phone Number: 0033390406150; Email: clinicaltrials@domaintherapeutics.com

Study Locations

• Australia
  • New South Wales
    • North Ryde, New South Wales, Australia, 2109
      • Recruiting
      • MacQuarie University Clinical Trial Unit
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research SA
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Peninsula & South Eastern Haematology & Oncology Group
    • Malvern, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Health Limited
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • One Clinical Research Pty Ltd
• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonie
  • Strasbourg, France, 67200
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
  • Villejuif, France, 94800
    • Recruiting
    • Institut Gustave Roussy
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Not yet recruiting
      • Honor Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A; Dose escalation of DT-7012 as a single agent	Drug: DT-7012; Intravenous infusion
Experimental: Part 1B; Dose escalation of DT-7012 in combination with an ICI	Drug: DT-7012; Intravenous infusion; Drug: Immune checkpoint inhibitor; Intravenous infusion
Experimental: Phase 2; Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.	Drug: DT-7012; Intravenous infusion; Drug: Immune checkpoint inhibitor; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Cycle 1 (21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	From the first dose of study drug until the date of end of treatment, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Domain Therapeutics Australia Pty Ltd
• Collaborators: Domain Therapeutics SA

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Immune Checkpoint Inhibitors
• Other Study ID Numbers: DT-7012-CLI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No