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Monoclonal Antibodies

SGN-35T for Cutaneous T-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

An Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.

Participants must have a detectable CD30 expression level (≥1%) in tumor tissue (except cHL and ALCL where CD30 is universally expressed).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

Study Summary

This trial is looking at a type of cancer called lymphoma, which affects the blood cells that fight infections. The trial will enroll people with different types of lymphoma. The trial is testing a drug

Who is the study for?

This trial is for adults with advanced lymphomas, such as Hodgkin's and various T-cell lymphomas, who have tried other treatments without success or for whom no standard treatment is appropriate. Participants must have a certain level of CD30 expression in their tumors (except for specific types where it's always present) and be physically able to undergo the treatment, with an ECOG score ≤1.Check my eligibility

What is being tested?

SGN-35T, a new drug delivered through vein infusion, is being tested for safety and effectiveness in treating different types of lymphoma. The trial has three parts: determining the best dose and schedule (Parts A & B), then assessing its safety at that dose while checking if it works against select lymphomas (Part C).See study design

What are the potential side effects?

Since SGN-35T is new and this is its first use in humans, part of the study aims to identify side effects which are currently unknown but will include any adverse reactions participants experience besides the intended therapeutic effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My tumor shows CD30 expression.

Select...

My cancer returned or worsened after treatment, including one with brentuximab vedotin.

Select...

I have received or was not eligible for anti-PD-1 therapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

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 more

Secondary outcome measures

Complete response (CR) rate as assessed by the investigator

Duration of response (DOR)

Number of participants with antidrug antibodies (ADA)

+4 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

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Multiple organ dysfunction syndrome

Neuropathy peripheral

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

Methotrexate or Bexarotene

Trial Design

1Treatment groups

Experimental Treatment

Group I: SGN-35TExperimental Treatment1 Intervention

SGN-35T monotherapy

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

74,118 Total Patients Enrolled

Tara Chen, PharmDStudy DirectorSeagen Inc.

Tara ChenStudy DirectorSeagen Inc.

1 Previous Clinical Trials

170 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical trial is actively seeking individuals to participate. The initial posting of the trial occurred on January 31st, 2024, with subsequent updates made until December 21st, 2023. The study aims to enroll a total of 110 participants at one designated site."

Answered by AI

What is the primary purpose of conducting this medical study?

"The primary objective of this investigation is to evaluate the incidence of adverse events (AEs) among participants, and this assessment will occur within a timeframe of approximately 21 days. Secondary outcomes consist of determining the complete response (CR) rate as determined by the investigator, which refers to the percentage of individuals exhibiting CR. Additionally, we aim to identify the number of subjects developing antidrug antibodies (ADA), summarized using descriptive statistics. Lastly, pharmacokinetic (PK) parameter analysis will include evaluating the area under concentration-time curve (AUC), also assessed through descriptive statistics."

Answered by AI

What is the overall count of individuals partaking in this medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on January 31st, 2024 and underwent its most recent revision on December 21st, 2023. A total of 110 individuals are being sought to participate in this study, which will be conducted at a single research site."

Answered by AI

Has the Food and Drug Administration granted approval to SGN-35T for clinical use?

"Based on the classification of this trial as Phase 1, indicating limited data supporting safety and efficacy, our team at Power rates the safety of SGN-35T with a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety Study of SGN-35T in Adults With Advanced Cancers

2024. "A Safety Study of SGN-35T in Adults With Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120504.

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