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Monoclonal Antibodies
SGN-35C for Anaplastic Large Cell Lymphoma
Phase 1
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with detectable CD30 expression level (≥1%) in tumor tissue from the most recent biopsy obtained at or after relapse
Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new drug called SGN-35C on people with different types of lymphoma, a type of cancer that affects infection-fighting blood cells. The study will focus on the
Who is the study for?
This trial is for adults with certain types of lymphoma, including classical Hodgkin, peripheral T cell, and diffuse large B cell lymphomas. Participants must have tried several treatments already or be ineligible/refused them. They need a performance status score ≤1 and must provide tissue to check CD30 expression in their tumors.Check my eligibility
What is being tested?
SGN-35C is being tested for the first time in humans to treat various lymphomas. The study has three parts: determining the best dose and schedule (Parts A & B) and assessing safety/effectiveness at that dose (Part C).See study design
What are the potential side effects?
As SGN-35C is new, side effects are unknown but will be closely monitored throughout the trial. Side effects refer to any unintended physical changes caused by the drug apart from treating the disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My latest biopsy shows my tumor has CD30 expression of 1% or more.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I have a type of lymph cancer and no standard treatment works for me, but I can try SGN-35C.
Select...
My cancer shows up on PET scans and can be measured with a CT scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
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 modifications due to AEs
+2 moreSecondary outcome measures
Apparent terminal half-life (t1/2)
Area under the concentration time curve (AUC)
CR rate as assessed by the investigator
+6 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
1Treatment groups
Experimental Treatment
Group I: SGN-35CExperimental Treatment1 Intervention
SGN-35C Monotherapy
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
74,058 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,660 Previous Clinical Trials
983,659 Total Patients Enrolled
Tara ChenStudy DirectorSeagen Inc.
1 Previous Clinical Trials
110 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants being recruited for this research project?
"Indeed, information available on clinicaltrials.gov indicates that this research study is actively seeking eligible participants. The trial was initially listed on May 31, 2024, and its most recent update occurred on April 19, 2024. Recruitment aims to enlist a total of 170 individuals at one designated site."
Answered by AI
Has the drug SGN-35C received approval from the FDA?
"Based on the early stage of this trial, our team at Power rates SGN-35C's safety as 1 out of 3. This is due to the preliminary nature of Phase 1 trials with limited data supporting both safety and efficacy."
Answered by AI
Are participants currently being recruited for this ongoing clinical trial?
"Indeed, as per clinicaltrials.gov, this investigation is currently in search of suitable participants. Originally shared on May 31st, 2024 and last modified on April 19th, 2024; the study aims to recruit a total of 170 patients from a single site."
Answered by AI
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