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Monoclonal Antibodies

SGN-CEACAM5C for Advanced Cancers

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 B (dose optimization) and Part C (dose expansion), participants must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy

Participants in Part A (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy with relapsed, refractory, or progressive disease and no appropriate standard therapy available at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of study and up to approximately 2 years

Awards & highlights

Study Summary

This trial is studying an experimental drug to treat solid tumor cancers that are hard to treat or have spread throughout the body.

Who is the study for?

This trial is for adults with advanced solid tumors that have returned, are resistant to treatment, or can't be removed by surgery. Participants must have specific types of cancer like colorectal, stomach, lung (non-small and small cell), or pancreatic cancer without standard treatment options available.Check my eligibility

What is being tested?

SGN-CEACAM5C is being tested in this study. It's an experimental drug known as an antibody-drug conjugate designed to target and kill cancer cells. The trial has three parts: determining the right dosage (Parts A and B) and assessing safety and effectiveness at that dose (Part C).See study design

What are the potential side effects?

Potential side effects may include damage to normal cells due to the drug sticking to them besides cancer cells. Specific side effects aren't listed but typically ADCs can cause fatigue, nausea, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed to be advanced and cannot be removed by surgery.

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My cancer is advanced, cannot be surgically removed, and has not responded to treatment.

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I am fully active or can carry out light work.

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I have colorectal, gastric, lung, or pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of study and up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of study and up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study and up to approximately 2 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 dose modifications due to AEs

Number of participants with DLTs by dose level

Number of participants with adverse events (AEs)

+2 more

Secondary outcome measures

Best response

Duration of response (DOR)

Number of participants with antidrug antibodies (ADAs)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SGN-CEACAM5CExperimental Treatment1 Intervention

SGN-CEACAM5C monotherapy

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

73,818 Total Patients Enrolled

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,570 Total Patients Enrolled

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,419 Total Patients Enrolled

Frequently Asked Questions

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

What is the scope of participation in this trial?

"To properly evaluate the chosen intervention, 410 qualified applicants are needed for this trial. These individuals can be found at sites such as South Texas Accelerated Research Therapeutics in San Antonio and START Mountain Region in West Valley City."

Answered by AI

How has the safety profile of SGN-CEACAM5C been assessed?

"With limited clinical data available to evaluate both safety and efficacy, our team has assigned SGN-CEACAM5C a score of 1."

Answered by AI

Are there any opportunities for enrollment in this experiment?

"Yes, according to clinicaltrials.gov this research is currently seeking participants who meet the criteria. The trial was first announced on December 31st 2023 and last updated November 21st 2023; it requires 410 patients from 3 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

2023. "A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06131840.

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