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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within specified tumor types
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including esophageal, breast, lung cancers and more. Participants must have relapsed or be intolerant to standard treatments. They should not have received prior therapies that caused severe immune reactions and must not have active brain metastases or serious infections.Check my eligibility
What is being tested?
SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy drugs cisplatin or carboplatin, is being tested across four parts of the study to determine safety and effectiveness in treating various solid tumors.See study design
What are the potential side effects?
Potential side effects include those common to cancer treatments such as fatigue, nausea, allergic reactions but also specific ones related to SGN-B6A which will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My tumor can be biopsied, and I agree to undergo this procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
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 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part D: sigvotatug vedotin combination therapy in 1L NSCLCExperimental Treatment3 Interventions
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Group II: Part D: sigvotatug vedotin combination therapy in 1L HNSCCExperimental Treatment4 Interventions
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Group III: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCExperimental Treatment4 Interventions
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Group IV: Part B: Dose expansionExperimental Treatment1 Intervention
sigvotatug vedotin monotherapy
Group V: Part A: Dose escalationExperimental Treatment1 Intervention
sigvotatug vedotin monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
cisplatin
1997
Completed Phase 3
~3290
carboplatin
2010
Completed Phase 3
~4790
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
68,333 Total Patients Enrolled
Scott Knowles, MD, PhDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
222 Total Patients Enrolled
Jonathan Hayman, MDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
160 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed to be advanced and cannot be removed by surgery.I have head and neck squamous cell cancer.My lung's ability to transfer gas is less than half of what's expected.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with esophageal squamous cell carcinoma.I have been diagnosed with non-small cell lung cancer.I stopped a treatment because of a severe immune reaction.I haven't had a severe infection in the last 2 weeks.I have mild to moderate nerve damage and am in the cisplatin or carboplatin group, or I have moderate to severe nerve damage in other groups.I have taken specific medications before.I have a severe lung condition not caused by my cancer.I haven't had another cancer in the last 3 years.My tumor can be biopsied, and I agree to undergo this procedure.I have brain metastases that are currently active or have been treated.I have cancer cells in the fluid around my brain and spinal cord.I have or might have lung inflammation that imaging tests could not rule out.My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.My condition is specified in the trial's disease focus.My breast cancer is advanced and not HER2-positive.
Research Study Groups:
This trial has the following groups:- Group 1: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
- Group 2: Part A: Dose escalation
- Group 3: Part B: Dose expansion
- Group 4: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
- Group 5: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 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
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