Study on DT-7012 Alone and with an Immune Checkpoint Inhibitor for Advanced Solid Tumors

Sponsor: Domain Therapeutics Australia Pty Ltd

Sponsor score: 0

ClinicalTrials ID:NCT06819735

Provider View

This clinical trial is testing a new drug, DT-7012, both by itself and with another type of cancer treatment called an immune checkpoint inhibitor. The study aims to find out if these treatments are safe and effective for adults with certain advanced solid tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment called DT-7012, which is an anti-CCR8 monoclonal antibody. The trial is in two phases and will test DT-7012 alone and in combination with an immune checkpoint inhibitor in adults with advanced solid tumors that have returned or spread. The main goals are to determine the safest dose, understand how the drug works in the body, and see if it can help shrink tumors.

Description

This clinical trial is divided into two main parts: Phase 1 and Phase 2.

In Phase 1, researchers will test different doses of DT-7012 to find the highest dose that can be given safely, both alone and with an immune checkpoint inhibitor. This phase will help determine how well patients tolerate the treatment and what side effects might occur.

Phase 1 includes:

  • Testing DT-7012 alone to find the best dose.
  • Testing DT-7012 with an immune checkpoint inhibitor, based on safety data from the first part.

In Phase 2, the study will focus on how effective DT-7012 is at treating specific types of cancer when used alone or with an immune checkpoint inhibitor. This phase will involve patients with certain advanced cancers to see if the treatment can help control their disease.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a solid tumor that is advanced or has spread, and has returned after treatment.
  • The cancer must be measurable by standard criteria.
  • Have at least one tumor that can be biopsied.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Have unresolved side effects from previous cancer treatments, except for hair loss.
  • Have had severe immune-related side effects from past treatments that led to stopping immunotherapy.
  • Have had major surgery or significant injury within the last 4 weeks that has not fully healed.
  • Have had radiation therapy within the last 4 weeks, or limited radiation for symptom relief within the last 2 weeks.
  • Have previously received treatment with an anti-CCR8 monoclonal antibody in a clinical trial.

Locations

FACILITYZIPCITYSTATE
Honor Health Research Institute85258ScottsdaleArizona

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