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SGN-BB228 for Melanoma

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Seagen Inc.

Must not be taking: CD228, 4-1BB

Disqualifiers: Other malignancy, CNS metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

See 8 more

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.

See 1 more

Trial Timeline

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

Treatment Details

Interventions

SGN-BB228 (Monoclonal Antibodies)

Trial OverviewSGN-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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PF-08046049Experimental Treatment1 Intervention

PF-08046049 monotherapy