What side effects are associated with this type of intervention?

Common treatments for skin cancer, such as systemic therapies, topical treatments, and photodynamic therapy, have various side effects. Systemic therapies like SGN-BB228, which are used for advanced melanoma and other solid tumors, often cause side effects such as headache, increased creatinine phosphokinase levels, and skin irritation. Topical treatments like imiquimod 5% cream can lead to local side effects, including mild to moderate skin reactions and scarring. Photodynamic therapy may cause pain during treatment, which can be managed with analgesia. These side effects vary in severity and frequency depending on the specific treatment and patient response.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of skin cancers. For melanoma, drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo), which are immune checkpoint inhibitors, have been approved. Additionally, targeted therapies such as vemurafenib (Zelboraf) and dabrafenib (Tafinlar) for BRAF-mutant melanoma have also received approval. For basal cell carcinoma, the FDA has approved hedgehog pathway inhibitors like vismodegib (Erivedge) and sonidegib (Odomzo). These treatments are similar to investigational drugs like SGN-BB228, which are being studied for their efficacy in treating advanced solid tumors, including melanoma.

What other types of research exist?

Promising alternatives to SGN-BB228 for skin cancer patients include sonidegib, which is FDA-approved for locally advanced basal cell carcinoma, and dovitinib, an inhibitor of FGF, VEGF, and platelet-derived growth factor receptors, which has shown preliminary efficacy in advanced melanoma. Both treatments have undergone significant clinical evaluation and may offer effective options for patients.

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Monoclonal Antibodies

SGN-BB228 for Melanoma

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

Participants must have disease that is relapsed, refractory, or intolerant to standard of care

Participants must have histologically or cytologically confirmed metastatic malignancy

Must not have

Prior therapies cannot include any drugs targeting CD228 or 4-1BB

Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SGN-BB228 to see if it can help treat difficult-to-treat cancers like melanoma and other solid tumors. The study will determine the safest amount of the drug to give and check if it works in shrinking or eliminating these tumors. The goal is to find a new treatment option for patients whose cancers are not responding to current therapies.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including melanoma and lung cancer, that are difficult to treat or have spread. Participants must have tried specific therapies before, like anti-PD-1 drugs for melanoma. They should be relatively healthy (ECOG score of 0 or 1) and not have had other cancers in the last 3 years.

What is being tested?

SGN-BB228 is being tested in this study to determine its safety and effectiveness against various solid tumors. The trial has three parts: Parts A and B will decide the right dose; Part C will test if it's safe at that dose and if it helps treat these cancers.

What are the potential side effects?

While the exact side effects of SGN-BB228 aren't listed here, common ones from similar treatments include fatigue, nausea, skin reactions at injection sites, immune-related issues affecting organs, muscle aches, feverish symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My condition has not improved with standard treatments.

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My cancer has spread and this was confirmed through lab tests.

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My melanoma cannot be removed by surgery and has spread.

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I have one of the following cancers: melanoma, lung, colorectal, pancreatic, or mesothelioma.

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I have been treated with drugs targeting PD-1 or PD-L1 before.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have not been treated with drugs targeting CD228 or 4-1BB.

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I haven't had cancer treatments like immunotherapy within 4 weeks before starting the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Duration of response (DOR)

Number of participants with antidrug antibodies

Objective response rate (ORR)

+7 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-08046049Experimental Treatment1 Intervention

PF-08046049 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 skin cancer include surgical excision, photodynamic therapy, immunotherapy, and targeted therapy. Surgical excision involves physically removing the cancerous tissue, which is effective for localized tumors. Photodynamic therapy uses a photosensitizing agent activated by light to destroy cancer cells. Immunotherapy, such as checkpoint inhibitors, boosts the body's immune system to recognize and attack cancer cells. Targeted therapies, like BRAF inhibitors, specifically target genetic mutations within cancer cells to inhibit their growth. These treatments are crucial for skin cancer patients as they offer various approaches to manage and potentially cure the disease. Investigational drugs like SGN-BB228 are being studied to determine their safety and effectiveness in treating hard-to-treat or metastatic solid tumors, including melanoma, by potentially offering new mechanisms to target and destroy cancer cells.