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Monoclonal Antibodies

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with DLTs by dose level

Number of participants with adverse events (AEs)

Number of participants with dose limiting toxicities (DLTs)

+1 more

Secondary outcome measures

Duration of response (DOR)

Number of participants with antidrug antibodies (ADAs)

Objective response rate (ORR)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SGN-EGFRd2Experimental Treatment1 Intervention

SGN-EGFRd2 monotherapy

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

73,953 Total Patients Enrolled

Corinna Palanca-WesselsStudy DirectorSeagen Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does SGN-EGFRd2 compare in terms of safety when compared to similar treatments?

"Due to a lack of data related to its efficacy and safety, SGN-EGFRd2 has been assigned an initial score of 1."

Answered by AI

Are there any openings currently available in this clinical research program?

"Clinicaltrials.gov displays that this clinical trial is currently accepting applicants, with the initial post-date being October 31st of 2023 and a subsequent update on October 24th of the same year."

Answered by AI

What is the purport of this clinical trial?

"Per the clinical trial sponsor Seagen Inc., this study aims to quantify laboratory abnormalities over a 90 day period following completion of treatment. Secondary outcomes will be assessed with respect to pharmacokinetic parameters like Area under Curve, Maximum Concentration, and Time to Maximum Concentration; these metrics are summarily described through descriptive statistics."

Answered by AI

To what extent is this scientific exploration being enacted by volunteers?

"Affirmative, clinicaltrials.gov lists this clinical trial as actively recruiting patients since its initial posting on October 31st 2023 and most recent update of October 24th 2022. This research requires 275 participants from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SGN-EGFRd2 in Advanced Solid Tumors

2023. "A Study of SGN-EGFRd2 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05983133.

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