Study on TROP2 ADC LCB84 Alone and with Anti-PD-1 Antibody for Advanced Solid Tumors

Sponsor: LigaChem Biosciences, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05941507

Provider View

This clinical trial is testing a new drug, LCB84, both by itself and in combination with another drug, an anti-PD-1 antibody, to see if it is safe and effective for treating advanced solid tumors that have not responded to standard treatments.

Patient Parameters

Program Overview

This study is the first to test a new treatment called LCB84, which targets a protein called TROP2 found on some cancer cells. The study is in two parts: Phase 1 will find the best dose of LCB84 alone, and Phase 2 will test LCB84 with an anti-PD-1 antibody. The trial is for patients with advanced solid tumors that have not responded to other treatments. In Phase 1, the study will determine the safest dose of LCB84 alone, and then test it in combination with the anti-PD-1 antibody. In Phase 2, the study will expand to include more patients with specific types of tumors to see how well the combination works.

Eligibility Criteria

Inclusion Criteria

  • Have advanced solid tumors that have not responded to standard treatments.
  • For Phase 2, have specific types of advanced solid tumors based on results from Phase 1.
  • Previous treatment with TROP2-targeted therapy is allowed.
  • Have measurable disease as defined by specific medical criteria.
  • Willing to provide a previous tumor sample or undergo a biopsy if needed.
  • Agree to have biopsies before and during treatment if medically safe.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ function, including:
    • Neutrophil count of at least 1500/µL without recent growth factor support.
    • Platelet count of at least 100,000/µL.
    • Hemoglobin level of at least 9.0 g/dL.
    • Liver enzymes within specified limits, unless liver metastases are present.

Exclusion Criteria

  • Have active or worsening cancer spread to the brain or spinal fluid.
    • Patients with stable or treated brain metastases may be eligible if:
      • Treatment for brain metastases was completed at least 4 weeks before starting the study.
      • No new or worsening neurological symptoms and no need for immediate treatment, steroids, or anticonvulsants.
      • Stable brain metastases for at least 1 month before the study.
  • Have ongoing side effects from previous cancer treatments that are more than mild, except for hair loss and skin color changes.
  • Have received cancer treatment within a short time before starting the study.
  • Are taking systemic steroids at a dose higher than 10 mg of prednisone per day, except for brain metastases as described above.

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