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

NCT06819735 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DT-7012-CLI-001
• Study Type: interventional
• Target: 125
• Locations: 3 countries
• Sites: 9

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective response rate (ORR)

  From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months

• Serum concentrations of DT-7012

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

Study Arms (3)

Part 1A

EXPERIMENTAL

Dose escalation of DT-7012 as a single agent

Drug: DT-7012

Part 1B

EXPERIMENTAL

Dose escalation of DT-7012 in combination with an ICI

Drug: DT-7012; Drug: Immune checkpoint inhibitor

Phase 2

EXPERIMENTAL

Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.

Drug: DT-7012; Drug: Immune checkpoint inhibitor

Interventions

Immune checkpoint inhibitor DRUG

Intravenous infusion

Part 1B; Phase 2

DT-7012 DRUG

Intravenous infusion

Part 1A; Part 1B; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Domain Therapeutics Australia Pty Ltd: lead
• Domain Therapeutics SA: collaborator

Study Sites (9)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

Macquarie University Clinical Trial Unit

North Ryde, New South Wales, 2109, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, 5000, Australia

RECRUITING

Peninsula & South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Cabrini Health Limited

Malvern, Victoria, 3144, Australia

RECRUITING

One Clinical Research Pty Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67200, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Clinical Development

CONTACT

0033390406150; clinicaltrials@domaintherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); FR (3); US (1)