SGN-35T for Lymphoma

No longer recruiting at 47 trial locations

Overseen By Seagen Trial Information Support

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Seagen Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Other malignancy, Active cerebral disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, SGN-35T (also known as PF-08046045), to determine its safety and effectiveness for individuals with certain types of lymphoma, a cancer affecting infection-fighting blood cells. The trial seeks to identify the appropriate dose and investigate any potential side effects. Participants should have lymphoma without other standard treatment options and have experienced frequent recurrences or progression. Those who have undergone previous lymphoma treatments without success may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that PF-08046045/SGN-35T is likely to be safe for humans?

Research shows that SGN-35T, also known as PF-08046045, is in the early stages of testing for treating lymphoma. This marks its first test in humans. Earlier studies in the lab and on animals have shown that SGN-35T might be safe. In these studies, it appeared gentler on human bone marrow cells compared to a similar treatment called BV (Brentuximab Vedotin).

Since this treatment is just beginning human trials, detailed safety information is not yet available. It is crucial to observe how well participants tolerate the drug and to monitor for any side effects. This trial will gather that information to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lymphoma, which often include chemotherapy or radiation, SGN-35T offers a novel approach by using a targeted therapy. Researchers are excited because SGN-35T specifically targets cancer cells with minimal effect on healthy cells, potentially reducing side effects. Additionally, this treatment harnesses an innovative mechanism of action, delivering a potent cytotoxic agent directly to the lymphoma cells, which could improve effectiveness compared to traditional methods.

What evidence suggests that this treatment might be an effective treatment for lymphoma?

Research has shown that SGN-35T, also known as PF-08046045, has potential based on early lab studies. These tests demonstrated its effectiveness against lymphoma cells, similar to the drug brentuximab vedotin, which already treats some types of lymphoma. Early data suggest that SGN-35T might work well and could cause fewer side effects. The drug targets a protein called CD30, found on some lymphoma cells, aiding in its attack on the cancer. These findings provide a strong basis for exploring its potential in treating various types of lymphoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer's CD30 status does not affect my eligibility.

To be eligible for the study, those who have not had ASCT must either decline the treatment or they are ineligible.

My condition is specified in the trial's disease focus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive SGN-35T to determine the best dose and dosing schedule

Approximately 12 weeks

Treatment Part B

Continuation of dose determination and schedule optimization for SGN-35T

Approximately 12 weeks

Treatment Part C

Participants receive the determined dose to evaluate safety and efficacy

Approximately 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days after last study treatment

What Are the Treatments Tested in This Trial?

Interventions

• SGN-35T

Trial Overview

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).

How Is the Trial Designed?

Group I: PF-08046045 Experimental Treatment 1 Intervention

monotherapy

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06120504

NCT06120504 | A Safety Study of PF-08046045/SGN-35T ...

This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity ...

2.

aacrjournals.org

aacrjournals.org/mct/article/22/12_Supplement/C132/730593/Abstract-C132-SGN-35T-A-novel-CD30-directed

Abstract C132: SGN-35T: A novel CD30-directed antibody ...

SGN-35T displayed comparable activity to brentuximab vedotin against three lymphoma cell lines in vitro, and complete or near-complete tumor ...

3.

firstwordpharma.com

firstwordpharma.com/story/5797432

Seagen Highlights First Solid Tumor Data for an ...

Preclinical data suggest that SGN-35T may be highly effective, like ADCETRIS, with the potential for improved tolerability.

4.

jitc.bmj.com

jitc.bmj.com/content/11/Suppl_1/A1271

1155 Activated regulatory T cells in solid tumors express ...

Together, these data support future clinical investigation of SGN-35T in combination with anti-PD-1/PD-L1 checkpoint inhibitors in solid tumors.

5.

withpower.com

withpower.com/trial/phase-1-lymphoma-2024-3d25e

SGN-35T for Lymphoma · Info for Participants

Trial Overview SGN-35T, a new drug delivered through vein infusion, is being tested for safety and effectiveness in treating different types of lymphoma. The ...

6.

delta.larvol.com

delta.larvol.com/Products/?ProductId=43248506-1920-47c8-98d0-d8349c6aff65

PF-08046045 / Pfizer - Non-Hodgkin's Lymphoma

Delicious. October 31, 2024. OPEN-LABEL PHASE 1 STUDY TO EVALUATE THE SAFETY OF SGN-35T ... - "Preclinical data suggest that SGN-35T may be highly effective ...

7.

bioworld.com

bioworld.com/articles/702058-cd30-directed-antibody-drug-conjugate-sgn-35t-for-the-treatment-of-lymphoma

CD30-directed antibody-drug conjugate SGN-35T for the ...

SGN-35T showed an improved non-clinical safety profile compared to BV on human bone marrow progenitor cells in human granulocyte-monocyte colony ...

8.

mskcc.org

mskcc.org/cancer-care/clinical-trials/24-226

A Phase 1 Study of SGN-35T in People with Lymphoma

Full Title An Open-label Phase 1 Study to Evaluate the Safety of SGN-35T in Adults with Advanced Malignancies Purpose Researchers want to find the best dose ...