Study on the Safety and Effectiveness of CAB-AXL-ADC in Adults and Teens with Sarcoma

Sponsor: BioAtla, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03425279

Provider View

This clinical trial is testing a new treatment called mecbotamab vedotin (BA3011) to see if it is safe and effective for patients with advanced solid tumors, including different types of sarcoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment, mecbotamab vedotin (BA3011), in patients with advanced solid tumors. The study is divided into two phases. Phase 1 has already been completed and involved testing different doses of the treatment. Phase 2 is ongoing and is split into two parts. Part 1 is testing mecbotamab vedotin alone and in combination with another drug, nivolumab, in patients with various advanced sarcomas. Part 2 is specifically looking at its effects in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Description

This study is being conducted at multiple centers and is open-label, meaning both the researchers and participants know what treatment is being given. It is a Phase 1/2 study, which means it is focused on assessing the safety, how the body processes the drug (pharmacokinetics), the immune response to the drug, and its ability to fight tumors. The treatment being tested is a conditionally active biologic (CAB) that targets a protein called AXL, which is found on some cancer cells. The study aims to find out if this treatment can help patients with advanced solid tumors, including different types of sarcoma, by shrinking the tumors or stopping them from growing.

Eligibility Criteria

Inclusion Criteria

  • Must have a measurable tumor that can be tracked.
  • Must be 12 years or older (for Phase 2).
  • Must have good kidney function.
  • Must have good liver function.
  • Must have healthy blood cell counts.
  • Must be in good general health, able to carry out normal activities or only slightly restricted.
  • Must have a life expectancy of at least three months.

Exclusion Criteria

  • Cannot have serious heart disease.
  • Cannot have uncontrolled cancer that has spread to the brain.
  • Cannot have had severe allergic reactions to similar treatments or be allergic to any study medications.
  • Cannot have had major surgery within four weeks before starting the study treatment.
  • Cannot have had previous treatment with similar types of drugs.
  • Cannot have HIV, active hepatitis B, or hepatitis C infections.
  • Cannot be pregnant or breastfeeding.

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