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Monoclonal Antibodies

SGN-35C for 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
Must not have
Previous allogeneic stem cell transplant (SCT) meeting specific criteria
Received previous ASCT infusion <12 weeks prior to the first dose of SGN-35C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
No Placebo-Only Group

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.
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).
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 below
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My latest biopsy shows my tumor has CD30 expression of 1% or more.
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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.
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My cancer shows up on PET scans and can be measured with a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell transplant from a donor.
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I had a stem cell transplant less than 12 weeks ago.
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My cancer has spread to my brain or its coverings.
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I have been treated with a specific type of cancer drug linked to camptothecin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year 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 adverse events (AEs)
Secondary study objectives
Apparent terminal half-life (t1/2)
Area under the concentration time curve (AUC)
CR rate as assessed by the investigator
+6 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%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
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

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
210 Previous Clinical Trials
74,168 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,678 Previous Clinical Trials
989,928 Total Patients Enrolled
Tara ChenStudy DirectorSeagen Inc.
1 Previous Clinical Trials
18 Total Patients Enrolled
~113 spots leftby Feb 2028
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