Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DT-7012, Immune checkpoint inhibitor.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Drug DT-7012
Intravenous infusion - Drug Immune checkpoint inhibitor
Intravenous infusion
Primary outcome measures
- Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation [Time frame: Cycle 1 (21 days)]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 5 centers
- Macquarie University Clinical Trial Unit — North Ryde
- Cancer Research SA — Adelaide
- Peninsula & South Eastern Haematology & Oncology Group — Frankston
- Cabrini Health Limited — Malvern
- One Clinical Research Pty Ltd — Nedlands
France · 3 centers
- Institut Bergonié — Bordeaux
- Hôpitaux Universitaires de Strasbourg — Strasbourg
- Institut Gustave Roussy — Villejuif
United States · 1 center
- Honor Health Research Institute — Scottsdale
Identifiers
NCT: NCT06819735 · DT-7012-CLI-001