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Monoclonal Antibodies

SEA-TGT for Cancer

Phase 1
Waitlist Available
Research Sponsored by Seagen Inc.
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
No Placebo-Only Group

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.
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).
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 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

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 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 study objectives
Area under the concentration-time curve (AUC)
Complete response (CR) rate
Duration of CR
+8 more

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499
47%
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%
Neuropathy peripheral
2%
Multiple organ dysfunction syndrome
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1900

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,206 Total Patients Enrolled
Andres Forero-Torres, MDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
533 Total Patients Enrolled

Media Library

SEA-TGT (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04254107 — Phase 1
Cervical Cancer Research Study Groups: SEA-TGT + sasanlimab Combination Therapy (Part C), SEA-TGT Monotherapy (Parts A and B), SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
Cervical Cancer Clinical Trial 2023: SEA-TGT Highlights & Side Effects. Trial Name: NCT04254107 — Phase 1
SEA-TGT (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04254107 — Phase 1
~24 spots leftby Jan 2026
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