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Monoclonal Antibodies

SGN-B6A for Advanced Solid Tumors

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
Measurable disease per the RECIST v1.1 at baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will study whether a drug called SGN-B6A is safe for people with solid tumors, what its side effects are, and whether it works to treat cancer.

Eligible Conditions
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Cancer
  • Oral Squamous Cell Carcinoma
  • Breast Cancer
  • Pancreatic Cancer
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Bladder Cancer
  • Cervical Cancer
  • Stomach Tumors
  • Ovarian Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a detectable disease according to a specific set of guidelines at the beginning of the study.
Select...
You are able to perform everyday activities without any problem or with only a little limitation due to your cancer.
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You must have a confirmed diagnosis of advanced cancer that cannot be removed by surgery.
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You have a disease that has come back, not responded to treatment, or you cannot tolerate the standard treatments available.
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You have a type of cancer that has come back, not responded to treatment, or you can't tolerate the treatment, and you have already been treated with a platinum-based therapy and a PD-1/PD-L1 inhibitor if it applies to you.
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You have not received any previous treatment for advanced cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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 (DLTs)
Number of patients with laboratory abnormalities
Secondary outcome measures
Apparent terminal elimination half-life (t1/2)
Area under the concentration-time curve (AUC)
Concentration at the end of infusion (Ceoi)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part D: SGN-B6A combination therapy in 1L NSCLCExperimental Treatment3 Interventions
SGN-B6A + pembrolizumab +/- (carboplatin)
Group II: Part D: SGN-B6A combination therapy in 1L HNSCCExperimental Treatment4 Interventions
SGN-B6A + pembrolizumab +/- (carboplatin or cisplatin)
Group III: Part C: SGN-B6A combination therapy in NSCLC, HNSCC, ESCCExperimental Treatment4 Interventions
SGN-B6A + pembrolizumab +/- (carboplatin or cisplatin)
Group IV: Part B: Dose expansionExperimental Treatment1 Intervention
SGN-B6A monotherapy
Group V: Part A: Dose escalationExperimental Treatment1 Intervention
SGN-B6A monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
cisplatin
1997
Completed Phase 3
~3290
pembrolizumab
2018
Completed Phase 3
~6240

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
202 Previous Clinical Trials
67,409 Total Patients Enrolled
Scott Knowles, MD, PhDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
220 Total Patients Enrolled
Natalya Nazarenko, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

SGN-B6A (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04389632 — Phase 1
Gastroesophageal Junction Adenocarcinoma Research Study Groups: Part A: Dose escalation, Part B: Dose expansion, Part C: SGN-B6A combination therapy in NSCLC, HNSCC, ESCC, Part D: SGN-B6A combination therapy in 1L NSCLC, Part D: SGN-B6A combination therapy in 1L HNSCC
Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: SGN-B6A Highlights & Side Effects. Trial Name: NCT04389632 — Phase 1
SGN-B6A (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04389632 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned SGN-B6A as a legitimate remedy?

"Due to the limited data on efficacy and safety, our team has rated SGN-B6A's risk level at a 1 out of 3. This is because this clinical trial belongs to Phase 1."

Answered by AI

Are there any open enrollments for this clinical experiment currently?

"Indeed, the clinical trial is still open for enrolment. According to records on clinicaltrials.gov, this experiment was published in June 2020 and its latest update occurred in November 2022."

Answered by AI

How many sites are currently offering participation in this research?

"This medical experiment is being conducted at 8 different sites, situated in Houston, Portland, and San Antonio as well as several other locations. To reduce the burden of travel for participants, it would be beneficial to select a location close by when signing up."

Answered by AI

How many individuals have been enrolled in this investigational research?

"In order to successfully conduct this medical trial, 355 eligible patients must be enrolled. This can occur at various locations such as MD Anderson Cancer Center / University of Texas in Houston and Providence Portland Medical Center in Oregonf Texas in Houston and Providence Portland Medical Center in Oregon."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
How old are they?
65+
What site did they apply to?
MD Anderson Cancer Center / University of Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of SGN-B6A in Advanced Solid Tumors
2020. "A Study of SGN-B6A in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04389632.
All > Breast Cancer Boston > Head And Neck Cancer
~144 spots leftby Jul 2024
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