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

Phase 2RecruitingNCT06819735

Domain Therapeutics Australia Pty Ltd125 enrolled

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Advanced Solid Tumors

Interventions

DT-7012DRUG

Intravenous infusion

Immune checkpoint inhibitorDRUG

Intravenous infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Macquarie University Clinical Trial Unit

North Ryde, New South Wales, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

RECRUITING

Peninsula & South Eastern Haematology & Oncology Group

Frankston, Victoria, Australia

Outcomes

Primary Outcomes

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

Time frame: Cycle 1 (21 days)

Secondary Outcomes

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.

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

Serum concentrations of DT-7012 will be determined to evaluate the pharmacokinetics (PK) of DT-7012

Time frame: From the first dose of study drug until the date of end of treatment, assessed up to 12 months

Central Contacts

Clinical Development

CONTACT

0033390406150 clinicaltrials@domaintherapeutics.com

Data from ClinicalTrials.gov

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