Study on PBI-410 for Advanced Solid Tumors

Sponsor: Biohaven Therapeutics Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06384807

Provider View

This clinical trial is testing a new drug, PBI-410, alone and in combination with another drug, cemiplimab, to see if it is safe and effective for treating advanced solid tumors in adults who have already received other treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called PBI-410 for adults with advanced solid tumors that have not responded to previous treatments. The trial is divided into two parts: the first part will determine the safest dose of PBI-410, both alone and with cemiplimab, while the second part will test how well the treatment works in shrinking tumors.

Description

The trial is designed to test a new drug, PBI-410, which targets a protein called Trop-2 found on some cancer cells. The study will be conducted in two phases. In the first phase, researchers will find the safest dose of PBI-410, both on its own and when combined with another drug called cemiplimab. In the second phase, they will see how effective the treatment is in reducing tumors. Participants will be adults with advanced solid tumors that have not responded to standard treatments. The study will take place at multiple locations and will involve regular health checks to monitor safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have a solid tumor that cannot be removed by surgery or cured, and has not responded to standard treatments.
  • Have measurable disease according to specific medical criteria.
  • 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 blood, kidney, liver, and clotting function as determined by specific tests.
  • Have recovered from any side effects of previous treatments, except for hair loss and skin changes.
  • For those receiving PBI-410 with cemiplimab, have advanced or metastatic cancer that has been confirmed by lab tests and have received no more than two prior lines of systemic anti-cancer therapy.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have significant ongoing health issues.
  • Have untreated or symptomatic brain metastases or recent treatment for brain metastases.
  • Have serious eye conditions affecting the cornea.
  • Need supplemental oxygen for daily activities.
  • Have previously received treatments targeting Trop-2.
  • Have a history of lung diseases like pneumonia or fibrosis.
  • Have received any cancer treatment or experimental therapy recently.
  • Have severe allergies to similar drugs or ingredients in PBI-410.
  • For those receiving PBI-410 with cemiplimab, have allergies to cemiplimab or have had severe immune-related side effects from similar treatments.
  • Have had a stem cell or organ transplant.
  • Have a history of heart inflammation (myocarditis).

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