IRB #

STUDY00018303

Title

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to find out if tisotumab vedotin treats solid tumor cancer. We want to see if patients with your kind of cancer respond to the drug. We want to see how long it takes patients to respond to the study drug and how long the response lasts. We also want to learn more about any side effects patients experience during treatment with the study drug.We are asking patients with four types of solid tumor cancer to take part in this study. The four types are colorectal cancer (CRC), squamous non small cell lung cancer (NSCLC), pancreatic cancer, and squamous cell carcinoma of the head and neck (SCCHN).

Medical Condition(s)

Colorectal cancer (CRC),
Squamous non small cell lung cancer (NSCLC)
Pancreatic adenocarcinoma
Squamous cell carcinoma of the head and neck (SCCHN).

Eligibility Criteria

1. Men and women 18 years or older
2. Men and women with colorectal cancer (CRC), squamous non small cell lung cancer (NSCLC), pancreatic cancer, or squamous cell carcinoma of the head and neck (SCCHN).
3. Adequate organ function
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The study is planned to last for about 2 ½ years.

You will receive the study drug for as long as:
1. You and the investigator feel that you are tolerating the study drug
2. The investigator feels it is in your best interest to continue receiving study drug;
3. You follow directions of the investigator;
4. if you are female and able to become pregnant, you do not become pregnant.

After you stop receiving the study drug, you will have end of treatment visit within 30 days of your last dose to see how you are feeling. Thereafter, your investigator will continue to watch you for side effects and follow your condition every 3 months by telephone.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Seattle Genetics Inc.

Recruitment End

04/30/2020

Compensation Provided

No


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