Study on CAB-ROR2-ADC for Treating Advanced Breast, Head & Neck, Lung Cancer, and Melanoma

Sponsor: BioAtla, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03504488

Provider View

This clinical trial is testing a new treatment called CAB-ROR2-ADC to see if it is safe and effective for patients with advanced solid tumors, including breast, head & neck, lung cancer, and melanoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment called CAB-ROR2-ADC in patients with advanced solid tumors. The study will be conducted in two phases: Phase 1 will focus on finding the right dose, and Phase 2 will test the treatment alone or with another drug in specific types of cancer.

Description

This study is being conducted at multiple locations and is open to patients with advanced solid tumors. It aims to test a new treatment called CAB-ROR2-ADC, which is designed to target cancer cells. The study will have two parts:

  • Phase 1: This phase will determine the safest dose of CAB-ROR2-ADC and will include patients with various advanced cancers.
  • Phase 2: This phase will test the treatment's effectiveness in patients with specific cancers, such as non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), and melanoma. In this phase, the treatment may be used alone or combined with another drug that helps the immune system fight cancer.

Participants will receive the treatment and be monitored for side effects and how well the cancer responds. The study will also look at how the body processes the drug and whether it triggers an immune response.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced cancer that cannot be removed by surgery or has spread, and have tried all standard treatments without success.
  • Have cancer that can be measured by scans or tests.
  • For Phase 2, have specific types of cancer such as non-small cell lung cancer, triple negative breast cancer, or soft tissue sarcoma.
  • Be 18 years or older.
  • Have good kidney, liver, and blood function.
  • 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 a life expectancy of at least three months.

Exclusion Criteria

  • Have significant heart disease.
  • Have uncontrolled cancer that has spread to the brain or spinal cord.
  • Have had severe allergic reactions to similar treatments in the past.
  • Have had major surgery within four weeks before starting the study treatment.
  • Have previously received certain types of cancer treatments similar to CAB-ROR2-ADC.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Be pregnant or breastfeeding.

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