What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy regimens such as FOLFIRINOX and gemcitabine plus nab-paclitaxel. These treatments often cause side effects like nausea, diarrhea, neutropenia, fatigue, and neuropathy. Antibody-drug conjugates (ADCs) like SGN-CEACAM5C, which target cancer cells, may also cause side effects including fatigue, neutropenia, and potential off-target effects on normal cells. Overall, while these treatments can be effective, they are associated with significant toxicities that need to be managed carefully.

What prior FDA approvals exist?

As of now, there are no FDA-approved antibody-drug conjugates (ADCs) specifically for the treatment of pancreatic cancer. However, the FDA has approved several other treatments for advanced pancreatic cancer. These include chemotherapeutic agents such as gemcitabine, often used in combination with nab-paclitaxel, and the FOLFIRINOX regimen, which includes a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin. These treatments aim to improve survival and manage symptoms in patients with advanced pancreatic cancer.

What other types of research exist?

Promising novel alternatives to SGN-CEACAM5C for pancreatic cancer patients include: 1) GSK2857916 (belantamab mafodotin), an ADC targeting B-cell maturation antigen, which has shown efficacy in multiple myeloma and may have potential in solid tumors. 2) Pembrolizumab, an immune checkpoint inhibitor, which has been effective in various cancers and could be considered in combination with other therapies. 3) Cetuximab, an EGFR inhibitor, which has been used in combination with chemotherapy for other solid tumors and may offer benefits for pancreatic cancer patients.

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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

No Placebo-Only Group

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 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.

Exclusion Criteria

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

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I have been treated with a specific type of chemotherapy linked to an antibody.

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I have been treated with drugs targeting CEACAM5 before.

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My cancer has spread to my brain or its coverings.

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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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PF-08046050Experimental Treatment1 Intervention

PF-08046050 monotherapy

0 / 8Eligibility criteria met

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.