SGN-BB228 for Melanoma

Not currently recruiting at 65 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Seagen Inc.

Must not be taking: CD228, 4-1BB

Disqualifiers: Other malignancy, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PF-08046049/SGN-BB228, to evaluate its safety and effectiveness in treating melanoma and other challenging cancers. It targets cancers that have spread or resist standard treatments. The trial aims to determine the optimal dose and assess any side effects. Individuals with melanoma, lung, colorectal, pancreatic cancer, or mesothelioma who have not responded to other treatments might be suitable candidates. Participants must have a type of melanoma that is not acral, uveal, or mucosal and must have received specific previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had any immunotherapy, biologics, or other antitumor treatments within 4 weeks before starting the study drug, or within 2 weeks if your disease has progressed on treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that PF-08046049, also known as SGN-BB228, is being tested for safety in treating melanoma and other hard-to-treat solid tumors. This phase 1 study marks the early stages of testing in humans. The primary goal is to determine the drug's safety and identify potential side effects.

As a phase 1 study, information about its safety in humans remains limited. However, these studies are crucial for ensuring a treatment is safe enough for further testing. Researchers closely monitor participants for side effects to establish the safest dose.

In summary, while detailed safety data is not yet available, testing SGN-BB228 in humans indicates it has passed basic safety checks in lab and animal studies. Participants should discuss potential risks and benefits with their doctors before deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SGN-BB228 is unique because it targets melanoma cells differently than traditional treatments like immune checkpoint inhibitors or targeted therapies. Its novel mechanism of action aims to directly engage and stimulate the immune system to recognize and destroy cancer cells more effectively. Researchers are excited about this treatment because it has the potential to overcome resistance to existing therapies, offering new hope for patients who haven't responded to current options.

What evidence suggests that SGN-BB228 might be an effective treatment for melanoma?

Research has shown that SGN-BB228, also known as PF-08046049, may effectively treat melanoma, a type of skin cancer. This drug targets a specific protein on cancer cells, aiding the body's immune system in fighting the tumor. Early lab studies found that it works well alone and even better with other cancer treatments like checkpoint inhibitors. These initial results suggest that SGN-BB228 might help shrink tumors or slow their growth. However, more research with human participants is needed to confirm these effects. ^{3 4 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I am fully active or can carry out light work.

Exclusion Criteria

I have stable brain metastases and haven't taken corticosteroids for them in the last 7 days.

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

I haven't had another cancer or any cancer signs in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Parts A and B)

Determine the appropriate dosage of PF-08046049/SGN-BB228 for participants

7 months

Multiple visits (in-person)

Dose Expansion (Part C)

Evaluate the safety and efficacy of PF-08046049/SGN-BB228 in treating solid tumor cancers

7 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Through 30 days after the last study treatment

What Are the Treatments Tested in This Trial?

Interventions

• SGN-BB228

Trial Overview 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.

How Is the Trial Designed?

Group I: PF-08046049 Experimental Treatment 1 Intervention

PF-08046049 monotherapy

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Citations

1. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT05571839

Clinical Trial Details | Pfizer Oncology Development Website A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors ... Up to approximately 1 year. Outcome Measure. Overall survival (OS) ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT05571839

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma ... Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20562841

A Study of PF-08046049/​SGN-BB228 in Advanced ... The purpose of this study is to test the safety and side effects of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors ...

4. webfiles.pfizer.com webfiles.pfizer.com/file/01jqfrxb4cbq1p3f7844rqhtw7

PF-08046049, a tumor targeted 4-1BB agonist, synergizes ... Here, we present preclinical data demonstrating the MOA of BB228 as both a single agent and in combination with the checkpoint inhibitors (CPI) anti-PD-1 +/- ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05571839

PF-08046049/SGN-BB228 in Advanced Melanoma and Other ... This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have ...

6. dana-farber.org dana-farber.org/clinical-trials/23-191

A phase 1 study of PF-08046049/SGN-BB228 in advanced ... This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have ...

7. clinicaltrial.be clinicaltrial.be/en/details/82319?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Study of PF-08046049/SGN-BB228 in Advanced ... This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have ...