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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Domain Therapeutics Australia Pty Ltd
Study ID
NCT06819735
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DT-7012 — DRUG
    Intravenous infusion
  • Immune checkpoint inhibitor — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A
    Dose escalation of DT-7012 as a single agent
  • Experimental: Part 1B
    Dose escalation of DT-7012 in combination with an ICI
  • Experimental: Phase 2
    Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-

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Honor Health Research Institute· Scottsdale, AZ

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