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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
No Placebo-Only Group
Summary
This trial is testing a new drug called SGN-ALPV in patients with advanced solid tumors. It aims to find the right dosage and see if the drug is safe and effective.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events (AEs)
Secondary study objectives
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)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SGN-ALPVExperimental Treatment1 Intervention
SGN-ALPV monotherapy
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cervical cancer include surgery, radiation therapy, chemotherapy, and targeted therapies. Targeted therapies, such as those similar to SGN-ALPV, work by interfering with specific molecules involved in cancer growth and progression.
For example, antibody-drug conjugates combine an antibody that targets cancer cells with a cytotoxic drug, delivering the drug directly to the cancer cells and minimizing damage to normal cells. This targeted approach is particularly important for cervical cancer patients as it can reduce side effects and improve the effectiveness of the treatment.
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Who is running the clinical trial?
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,387 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.
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