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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
Must not have
Prior treatment with an antibody-drug conjugate (ADC) with a camptothecin payload
Previous exposure to CEACAM5-targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study and up to approximately 2 years
Awards & highlights
Summary
This trial is testing a new drug called SGN-CEACAM5C for patients with hard-to-treat solid tumors that have either returned or didn't respond to standard treatments. The drug targets cancer cells and kills them. The study will determine the safe dosage and effectiveness of the drug.
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.
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).
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 belowSelect...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Select...
My cancer is advanced, cannot be surgically removed, and has not responded to treatment.
Select...
I am fully active or can carry out light work.
Select...
I have colorectal, gastric, lung, or pancreatic cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a specific type of chemotherapy linked to an antibody.
Select...
I have been treated with drugs targeting CEACAM5 before.
Select...
My cancer has spread to my brain or its coverings.
Select...
I have not had another cancer or any remaining cancer from a past diagnosis in the last 3 years.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events (AEs)
Secondary study objectives
Best response
Duration of response (DOR)
Objective response rate (ORR)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PF-08046050Experimental Treatment1 Intervention
PF-08046050 monotherapy
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy regimens such as gemcitabine plus nab-paclitaxel and FOLFIRINOX, which work by interfering with the DNA replication process in rapidly dividing cancer cells, thereby inhibiting tumor growth. Platinum-based therapies, like gemcitabine plus cisplatin, induce DNA cross-linking, leading to cell death.
Antibody-drug conjugates (ADCs), such as SGN-CEACAM5C, represent a targeted approach where an antibody specifically binds to cancer cell antigens and delivers a cytotoxic drug directly to the tumor cells, minimizing damage to normal cells. These mechanisms are crucial for pancreatic cancer patients as they offer targeted and effective treatment options, potentially improving outcomes and reducing side effects.
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Who is running the clinical trial?
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,880 Total Patients Enrolled
SanofiIndustry Sponsor
2,191 Previous Clinical Trials
4,033,617 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,673 Previous Clinical Trials
988,025 Total Patients Enrolled
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