SGN-EGFRd2 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated: CRC, NSCLC, HNSCC, Pancreatic ductal adenocarcinoma (PDAC). Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. Measurable disease at baseline per RECIST 1.1 criteria.

For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types: Colorectal cancer (CRC), Non-small cell lung cancer (NSCLC), Head and neck squamous cell cancer (HNSCC).

Must not have

Participants with history of thromboembolic phenomena (pulmonary embolism, deep vein thrombosis, stroke, or ischemic attack) within 6 months prior to the first dose of study drug, currently receiving chronic anticoagulation therapy, or with contraindication to treatment for thromboembolism prophylaxis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety & effectiveness of a drug, SGN-EGFRd2, in people with advanced solid tumors. It will also measure side effects.

Who is the study for?

This trial is for adults with advanced solid tumors like colorectal, non-small cell lung, or squamous cell cancers that have spread and can't be removed. They should have tried other treatments without success or cannot tolerate them. Participants need to be in good physical condition (ECOG score of 0 or 1) and must not have had certain serious blood clots or another cancer within the last three years.

What is being tested?

SGN-EGFRd2 is being tested for safety and effectiveness in treating advanced solid tumors. The study has three parts: determining the right dose (Parts A & B) and then assessing its safety at that dose while checking if it helps treat these cancers (Part C).

What are the potential side effects?

While specific side effects are not listed, they generally include any unintended physical effects caused by SGN-EGFRd2 besides treating the tumor. These could range from mild discomforts to more severe reactions depending on how individuals respond to the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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For Part C, you must have a specific type of cancer that has come back, not responded to treatment, or you cannot tolerate standard treatments. You should have a good level of physical function and have a tumor that can be measured.

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My cancer has returned, is not responding, or I can't tolerate standard treatments. It's one of CRC, NSCLC, or HNSCC and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot or stroke in the last 6 months, am on blood thinners, or can't take blood clot prevention medication.