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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a drug for treating hard-to-treat solid tumors. It will also look at side effects.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)
Number of participants with dose limiting toxicities
Number of participants with laboratory abnormalities
Secondary outcome measures
Duration of response (DOR)
Number of participants with antidrug antibodies
Objective response rate (ORR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SGN-BB228Experimental Treatment1 Intervention
SGN-BB228 monotherapy

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
73,723 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,666 Previous Clinical Trials
986,130 Total Patients Enrolled
Jeremy Sauer, PhDStudy DirectorSeagen Inc.

Media Library

SGN-BB228 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05571839 — Phase 1
Skin Cancer Research Study Groups: SGN-BB228
Skin Cancer Clinical Trial 2023: SGN-BB228 Highlights & Side Effects. Trial Name: NCT05571839 — Phase 1
SGN-BB228 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571839 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SGN-BB228 been sanctioned by the FDA?

"Our team at Power evaluated SGN-BB228's safety with a score of 1 due to its Phase 1 status, which suggests data is lacking regarding the medication's efficacy and security."

Answered by AI

How many people are being admitted to the trial at this time?

"Affirmative. Clinicaltrials.gov has revealed that this clinical trial is currently recruiting, with the initial posting on November 30th 2022 and latest update taking place on October 31st 2022. 275 individuals are being requested to partake in the study at 1 medical site."

Answered by AI

Are participants being recruited for this investigation?

"Indeed. The clinical trial's listing on clinicaltrials.gov confirms that it is actively seeking participants and has been since November 30th 2022, with the details most recently updated on October 31st 2022. A total of 275 patients must be recruited from one medical centre."

Answered by AI

What potential benefits are investigators hoping to attain through the course of this clinical trial?

"The primary outcome of this study, to be measured after 30 days following the last treatment and at 7 months, is the number of participants with laboratory abnormalities. Secondary objectives include a response rate evaluation, pharmacokinetic (PK) parameter- time to maximum concentration measurement summarised using descriptive statistics, as well as duration of response observation from initial documentation of objective tumor response until first documentation of progressive disease or death due to any cause."

Answered by AI
~142 spots leftby Oct 2025