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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Macquarie University Clinical Trial Unit
North Ryde, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Cabrini Health Limited
Malvern, Victoria, Australia
One Clinical Research Pty Ltd
Nedlands, Western Australia, Australia
Institut Bergonié
Bordeaux, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Gustave Roussy
Villejuif, France
Start Date
June 25, 2025
Primary Completion Date
September 1, 2027
Completion Date
January 1, 2028
Last Updated
March 10, 2026
125
ESTIMATED participants
DT-7012
DRUG
Immune checkpoint inhibitor
DRUG
Lead Sponsor
Domain Therapeutics Australia Pty Ltd
Collaborators
NCT06898450
NCT05719558
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07029399