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Study Summary
This trial will test the safety of a new drug for solid tumors. It will also study side effects. The study has three parts and will enroll participants who have metastatic or unresectable solid tumors.
- Esophageal Cancer
- Squamous Cell Carcinoma
- Ovarian Tumors
- Melanoma
- Breast Cancer
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have cancer that has spread to your brain and is still growing.You have a disease that affects the tissues surrounding the brain and spinal cord.You have received a certain type of medication called an anti-PD-L1 agent within a specific period of time.Your disease has come back after treatment, has not responded to treatment, or you cannot tolerate the approved treatments.You must have a certain level of PD-L1 expression based on past testing.The disease can be measured using specific guidelines at the start of the study.You must have been diagnosed with advanced non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, or triple negative breast cancer.Participants with head and neck cancer must have a confirmed diagnosis through tissue or cell tests.You should have a good ability to carry out daily activities without feeling limited by your health.You have had another type of cancer within the last 3 years, or there are signs that a previous cancer has not been completely treated.You have previously been treated with a drug containing monomethylauristatin E (MMAE).You have severe nerve damage before starting the study.You have cancer that has come back after treatment, or did not respond to standard treatments, and you have one of the following types of cancer: head and neck, lung, esophagus, ovary, skin, or triple-negative breast cancer. Your overall health status is good or fairly good, and your cancer can be measured by specific criteria.
- Group 1: SGN-PDL1V
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the Food and Drug Administration accorded approval to SGN-PDL1V?
"Our team at Power believes that SGN-PDL1V is relatively safe, rating it a 1 on the scale. This assessment is based upon its status as an early phase trial, with limited efficacy and safety data available."
Are there any locations in North America where this clinical investigation is taking place?
"At present, this clinical trial is enrolling participants at NEXT Oncology in Fairfax, Virginia; The University of Texas MD Anderson Cancer Center in Houston, Texas; and South Texas Accelerated Research Therapeutics in San Antonio, Utah. There are also 5 additional sites offering this medication."
Is this investigation open to recruitment?
"Affirmative. All information found on clinicaltrials.gov confirms that this medical experiment, which was initially declared on the 25th of October 2022, is still looking for participants. It requires 315 people to join from 5 distinct healthcare centres."
To what extent are participants engaging in this investigation?
"Affirmative, the information on clinicaltrials.gov reveals that this study is currently seeking individuals to enroll in their trial. Initially posted October 25th 2022 and last modified November 11th 2022, this research needs 315 participants from 5 different sites."
What therapeutic objectives are the researchers hoping to realize with this clinical trial?
"This study will last approximately one month and its primary outcome is the number of participants with adverse events. Secondary objectives include overall survival, objective response rate per RECIST v1.1 by investigator assessment, and pharmacokinetic parameters such as apparent terminal half-life."
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