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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат DT-7012
  Intravenous infusion
• Препарат Immune checkpoint inhibitor
  Intravenous infusion

Первичные конечные точки

• Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation [Срок оценки: Cycle 1 (21 days)]

Вторичные конечные точки (2)

• Objective response rate (ORR) [Срок оценки: From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months]
• Serum concentrations of DT-7012 [Срок оценки: From the first dose of study drug until the date of end of treatment, assessed up to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 5 центров

• 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

Франция · 3 центра

• Institut Bergonié — Bordeaux
• Hôpitaux Universitaires de Strasbourg — Strasbourg
• Institut Gustave Roussy — Villejuif

США · 1 центр

• Honor Health Research Institute — Scottsdale

Идентификаторы

NCT: NCT06819735 · DT-7012-CLI-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗