Study on CRB-701 for Treating Solid Tumors

Sponsor: Corbus Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06265727

Provider View

This clinical trial is testing a new drug, CRB-701, to find a safe and effective dose for treating solid tumors that have a specific protein called nectin-4. The study will involve giving the drug through an IV and monitoring its effects on the tumors.

Patient Parameters

Program Overview

The purpose of this study is to determine a safe and effective dose of CRB-701 for patients with solid tumors that have the nectin-4 protein. The study will explore how well CRB-701 works on its own and which types of cancer it can treat effectively. Participants will receive the drug through an IV and undergo blood tests and scans to see how the tumors respond.

Description

This clinical trial is divided into three parts and aims to evaluate the safety and effectiveness of CRB-701 in patients with advanced solid tumors that express the nectin-4 protein.

In Part A, the study will include different types of solid tumors known to have nectin-4. The goal is to find the maximum safe dose of CRB-701 by gradually increasing the dose and monitoring for any side effects.

Part B will focus on finding the best dose for future studies by testing two different doses of CRB-701 in patients with nectin-4-positive tumors.

In Part C, the study will use the best dose found in Part B to treat five different groups of patients, aiming to further understand the drug's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumors that express the nectin-4 protein.
  • The cancer must have progressed after at least one previous treatment or have no other standard treatment options available.

Exclusion Criteria

  • Have active or uncontrolled cancer that has spread to the brain or spinal cord.
  • Have a history of other solid tumors not related to the study.
  • Have had heart problems or conditions in the past 6 months.
  • Have existing nerve damage of a certain severity.
  • Have uncontrolled diabetes or diabetic nerve damage.
  • Have active eye disease at the start of the study.
  • Have severe liver disease or cirrhosis.
  • Have lung disease or inflammation within 6 months before starting the study.
  • Have other significant health issues.

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