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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 up to approximately 3 years
Awards & highlights
Study Summary
This trial will study a drug, SEA-TGT, to find out if it is safe and effective in treating patients with solid tumors and lymphomas.
Who is the study for?
This trial is for adults with certain advanced cancers (like lung, stomach, skin, breast cancer) or lymphomas that can't be removed by surgery. Participants should have a good performance status and measurable disease. They can't join if they've used certain treatments recently, have brain metastases, autoimmune diseases, a history of another cancer within 2 years (with some exceptions), or specific lung conditions.Check my eligibility
What is being tested?
The study tests SEA-TGT's safety and effectiveness in treating solid tumors and lymphomas. It has four parts: determining the right dose (Part A), assessing safety/effectiveness at that dose for solid tumors/lymphomas (Part B), combining SEA-TGT with sasanlimab for solid tumors (Part C), and combining it with brentuximab vedotin for Hodgkin lymphoma (Part D).See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting various organs, infusion-related reactions from the drug entering the body, fatigue, digestive issues like nausea or diarrhea, blood disorders such as low white cell counts increasing infection risk.
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 a dose-limiting toxicity (DLT) at each dose level
Number of participants with adverse events (AEs)
Number of participants with laboratory abnormalities by grade
Secondary outcome measures
Area under the concentration-time curve (AUC)
Complete response (CR) rate
Duration of CR
+8 moreSide effects data
From 2018 Phase 3 trial • 131 Patients • NCT0157849947%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene
Trial Design
3Treatment groups
Experimental Treatment
Group I: SEA-TGT Monotherapy (Parts A and B)Experimental Treatment1 Intervention
SEA-TGT
Group II: SEA-TGT + sasanlimab Combination Therapy (Part C)Experimental Treatment2 Interventions
SEA-TGT + sasanlimab
Group III: SEA-TGT + brentuximab vedotin Combination Therapy (Part D)Experimental Treatment2 Interventions
SEA-TGT + brentuximab vedotin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brentuximab vedotin
2010
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,025 Total Patients Enrolled
Andres Forero-Torres, MDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
417 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced non-small cell lung cancer, gastric or gastroesophageal junction carcinoma, melanoma, head and neck squamous cell carcinoma, bladder cancer, cervical cancer, ovarian cancer, or triple negative breast cancer.You have used certain medications or therapies in the past.You have cancer that has spread to your brain, spinal cord, or lining of the brain, or you have had a specific type of stem cell transplant.You have active cancer in your brain, lung disease, or an ongoing autoimmune condition.You have not finished your previous cancer treatment within a certain time period.You have been diagnosed with a specific type of cancer that has spread or advanced.You have lymphoma that has gotten worse after trying standard treatments.You have a disease that can be measured using certain criteria.You should be able to carry out all your usual activities without any restrictions (score of 0) or with a little restriction (score of 1).You have a lung condition that is not caused by an infection, or you have a history of lung inflammation caused by the immune system.
Research Study Groups:
This trial has the following groups:- Group 1: SEA-TGT Monotherapy (Parts A and B)
- Group 2: SEA-TGT + sasanlimab Combination Therapy (Part C)
- Group 3: SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
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.
In what quantity are medical facilities conducting this research?
"This clinical trial is recruiting patients from the University of Cincinnati Cancer Institute, Memorial Sloan Kettering Cancer Center, and University of Alberta / Cross Cancer Institute amongst a total 27 other medical centres."
Answered by AI
Is the enrollment phase of this clinical trial open to new participants?
"According to official records, this medical trial has been successfully recruiting candidates since its posting on May 29th 2020. The information was recently updated on October 14th 2022."
Answered by AI
What potential adverse effects have been observed from SEA-TGT treatments?
"Considering there is limited supporting evidence of SEA-TGT's efficacy and safety, it was assigned a risk score of 1."
Answered by AI
What purpose does this clinical experiment seek to achieve?
"This clinical trial, with a duration of 21 days, will measure the quantity of laboratory abnormalities among participants. Secondary targets include time to maximum concentration (tmax), duration of objective response and area under the concentration-time curve (AUC). Descriptive statistics shall be used for summarizing these outcomes."
Answered by AI
To what extent is the clinical trial being populated with participants?
"A total of 397 suitable participants are required for the study to commence. Seagen Inc., its sponsor, will be overseeing this trial from multiple regions, such as Cincinnati's University of Cincinnati Cancer Institute and New york City's Memorial Sloan Kettering Cancer Center."
Answered by AI
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