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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
Study Summary
This trial will test the safety of a new drug, SGN-ALPV, for people with solid tumors. It will also study the drug's side effects. The trial will have three parts, testing different doses to find the most effective and safe amount.
Who is the study for?
This trial is for adults with advanced solid tumors like stomach, cervical, testicular cancers and more. These tumors must be metastatic or unresectable. Participants need confirmed diagnoses and may require biopsies. They should not have had certain recent cancers or treatments that could interfere with the study.Check my eligibility
What is being tested?
SGN-ALPV is being tested to determine its safety and effectiveness in treating various solid tumor cancers. The trial has three parts: Parts A and B will establish the proper dose; Part C will assess how safe it is at that dose and if it helps treat cancer.See study design
What are the potential side effects?
While specific side effects of SGN-ALPV are not listed, they can include any unintended effect on your body besides treating the disease. This might involve reactions at the drug injection site, general discomforts like nausea or fatigue, or other organ-specific issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 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 DLTs by dose level
Number of participants with adverse events (AEs)
Number of participants with dose-limiting toxicities (DLTs)
+1 moreSecondary outcome measures
Apparent terminal half-life (t1/2)
Area under the concentration-time curve (AUC)
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SGN-ALPVExperimental Treatment1 Intervention
SGN-ALPV monotherapy
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,114 Total Patients Enrolled
Suzanne McGoldrick, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion means that individuals with ovarian cancer are included in the study.It seems like the criterion is incomplete. Could you please provide more details or context so that I can assist you accurately?You have endometrial cancer.Criterion: You have cervical cancer.You have moderate or severe nerve damage before the study starts.You have active cancer that has spread to your brain.You have had another type of cancer in the past three years, or still have signs of a previous cancer, with some exceptions.For certain types of tumors in Part C, you need to have specific disease progression and previous treatments to be eligible.You have taken certain types of medications before.Participants must have a confirmed advanced or inoperable solid tumor.You have a specific type of lung cancer called non-small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: SGN-ALPV
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.
Is SGN-ALPV considered a secure treatment for individuals?
"As this is a Phase 1 trial, there are only limited safety and efficacy data available for SGN-ALPV. As such, our team at Power assessed the drug's safety with a score of 1."
Answered by AI
Are there numerous centers conducting this trial in Canada?
"The current roster of 7 clinical trial sites includes Oklahoma City, Fairfax and Fresno. If you choose to enrol in the study, it is recommended that you select a clinic at close proximity to minimize transportation needs."
Answered by AI
How many individuals have enrolled in this trial thus far?
"Affirmative. Information available through clinicaltrials.gov verifies that the trial, initially posted on April 21st 2022, is actively recruiting. A total of 285 patients are necessary to be obtained across 7 different sites."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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