Study on BT7480 for Patients with Advanced Cancers Linked to Nectin-4

Sponsor: BicycleTx Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05163041

Provider View

This clinical trial is testing a new drug, BT7480, alone and with another drug called nivolumab, in patients with advanced cancers that show Nectin-4. The study aims to find the safest dose, understand side effects, and see how well the drug works, especially in patients with kidney issues.

Patient Parameters

Program Overview

This study is testing a new drug called BT7480, both by itself and with another drug called nivolumab, in patients with advanced solid tumors that have Nectin-4. The main goals are to find the safest dose, learn about side effects, see how well the drug works, and understand how the body processes it, especially in patients with kidney problems.

Description

BT7480 is a new type of drug designed to target cancer cells by binding to specific proteins, Nectin-4 and CD137. This study is the first time BT7480 is being tested in humans. It is divided into several parts:

  1. Phase 1: Testing different doses of BT7480 alone to find a safe dose and see how patients tolerate it.
  2. Phase 1: Testing BT7480 with nivolumab after finding a safe dose for BT7480 alone.
  3. Phase 2: Expanding the study to more patients using the safe dose of BT7480 alone.
  4. Phase 2: Expanding the study to more patients using the safe dose of BT7480 with nivolumab.
  5. Phase 1: Confirming the safe dose of BT7480 alone in patients with kidney problems.

The study will help determine the best dose for future research and provide insights into the drug's effects and safety.

Eligibility Criteria

Inclusion Criteria

  • Have advanced cancer that has not responded to standard treatments or for which no standard treatment is available.
  • Have a confirmed diagnosis of a solid tumor that shows Nectin-4, such as bladder, head and neck, lung, ovarian, breast, stomach, or esophageal cancer.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to standard criteria.
  • Have a life expectancy of at least 12 weeks.
  • Provide a fresh or previous tumor sample for analysis.
  • Agree to sign a written consent form before starting any study procedures.

Exclusion Criteria

  • Have received chemotherapy or other cancer treatments within 14 days before starting the study drug.
  • Have received immunotherapy, including certain antibodies, within 28 days or 5 half-lives before starting the study drug.
  • Have been treated with therapies targeting CD137.
  • Have a heart condition with a prolonged QT interval on an ECG.
  • Have uncontrolled brain cancer spread.
  • Have uncontrolled diabetes with high blood sugar levels.
  • Have uncontrolled high blood pressure.
  • Have a history of autoimmune diseases, except for well-controlled diabetes, hair loss, thyroid disease, or vitiligo.

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