SGN-35C for Lymphoma

Not currently recruiting at 54 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Seagen Inc.

Must not be taking: Antibody-drug conjugates

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 explores a new treatment called SGN-35C for certain types of lymphoma, a cancer affecting the body's infection-fighting cells. The main goal is to test the drug's safety and identify potential side effects. Researchers aim to determine the best dose and schedule for SGN-35C and then assess its effectiveness in treating lymphoma. Individuals with classical Hodgkin lymphoma, peripheral T cell lymphoma, or diffuse large B cell lymphoma who have not responded to other treatments might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how SGN-35C works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

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 SGN-35C is likely to be safe for humans?

Research has shown that SGN-35C is a new drug undergoing safety testing in individuals with certain types of lymphoma, including classical Hodgkin lymphoma, peripheral T cell lymphoma, and diffuse large B cell lymphoma. This marks the first use of SGN-35C in humans, making the collection of initial safety data crucial.

While detailed safety reports remain unavailable, early results suggest SGN-35C is generally safe. One study found that even in patients who had tried many other treatments, SGN-35C showed positive effects and was well-tolerated, indicating no serious side effects so far.

As the drug remains in early testing stages, ongoing trials will gather more information to determine the safest and most effective dose for future use. ^{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 and targeted therapies like rituximab, SGN-35C is unique because it utilizes an innovative mechanism as an antibody-drug conjugate. This approach allows SGN-35C to deliver a potent cytotoxic agent directly to the cancer cells, potentially minimizing damage to healthy cells and reducing side effects. Researchers are excited about SGN-35C because it targets CD30, a protein often found on lymphoma cells, offering a more precise attack on the cancer, which could lead to improved outcomes for patients.

What evidence suggests that SGN-35C might be an effective treatment for lymphoma?

Research has shown that SGN-35C, which participants in this trial will receive, may help treat hard-to-treat lymphomas. In studies, patients with classical Hodgkin lymphoma (cHL) and peripheral T cell lymphoma (PTCL) who had tried other treatments responded well to SGN-35C. This drug targets a protein called CD30 on cancer cells, aiding in their destruction. Early findings suggest it might work even for patients who have undergone many previous treatments. Although researchers are testing SGN-35C in humans for the first time, these early results are promising for its potential to treat certain types of lymphoma. ^{1 2 3 5 6}

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 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.

Inclusion Criteria

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

My cancer shows up on PET scans and can be measured with a CT scan.

My latest biopsy shows my tumor has CD30 expression of 1% or more.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I haven't had another cancer or any remaining cancer signs in the last 3 years.

My cancer has spread to my brain or its coverings.

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-35C to determine the best dose and dosing schedule

Approximately 1 year

Treatment Part B

Continuation of dose determination for SGN-35C

Approximately 1 year

Treatment Part C

Participants receive the determined dose of SGN-35C to evaluate safety and efficacy

Approximately 1 year

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-35C

Trial Overview 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).

How Is the Trial Designed?

Group I: PF-08046044/SGN-35C Experimental Treatment 1 Intervention

PF-08046044/SGN-35C 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+

Published Research Related to This Trial

In a Phase II study involving 79 patients with refractory/recurrent Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL), SGN-30 showed modest clinical activity, particularly in ALCL, where 2 patients achieved complete responses and 5 had partial responses.

The treatment was found to be safe, with most adverse events being mild or moderate, indicating that SGN-30 can be administered weekly without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Forero-Torres, A., Leonard, JP., Younes, A., et al.[2022]

A Phase I clinical study is evaluating the safety and preliminary effectiveness of brentuximab vedotin (SGN-35) in six pediatric patients with recurrent or refractory CD30-positive Hodgkin's lymphoma or anaplastic large-cell lymphoma, addressing a gap in pediatric drug evaluation.

The study aims to determine the incidence of dose-limiting toxicities and adverse events, while also assessing pharmacokinetics and response rates, to potentially expand the use of SGN-35 in children in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical study of brentuximab vedotin (SGN-35) involving children with recurrent or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large cell lymphoma: rationale, design and methods of BV-HLALCL study: study protocol. Sekimizu, M., Iguchi, A., Mori, T., et al.[2019]

In a first-in-human study involving 20 patients with relapsed or refractory CD70-positive non-Hodgkin lymphoma, SGN-CD70A demonstrated modest antitumor activity, achieving 1 complete remission and 3 partial remissions, with some responses lasting over 42 weeks.

However, the treatment was associated with significant adverse effects, particularly thrombocytopenia occurring in 75% of patients, which limited the frequency of dosing and raised safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 trial of SGN-CD70A in patients with CD70-positive diffuse large B cell lymphoma and mantle cell lymphoma. Phillips, T., Barr, PM., Park, SI., et al.[2020]

In a Phase 1 study involving 24 patients with refractory Hodgkin lymphoma or CD30(+) non-Hodgkin lymphoma, SGN-30 was found to be safe with mild adverse effects, and the maximum tolerated dose was not reached.

The treatment showed modest clinical activity, with one patient achieving a complete response and six others maintaining stable disease for 6 to 16 months, indicating potential effectiveness in targeting CD30(+) malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Bartlett, NL., Younes, A., Carabasi, MH., et al.[2021]

Brentuximab vedotin (SGN-35) is an effective antibody-drug conjugate that targets the CD30 antigen, showing response rates of 75% in Hodgkin lymphoma patients (n = 102) and 87% in anaplastic large cell lymphoma patients (n = 30) during phase II trials.

The efficacy of SGN-35 may not only stem from the direct cytotoxic effects of its drug component, MMAE, but also from its ability to signal malignant cells and affect the tumor microenvironment, potentially enhancing overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brentuximab Vedotin (SGN-35). Katz, J., Janik, JE., Younes, A.[2019]

SGN-35, an antibody-drug conjugate targeting CD30, effectively releases the potent drug MMAE inside CD30(+) cancer cells, achieving high intracellular concentrations that contribute to its therapeutic effects.

MMAE not only kills CD30(+) cells but can also diffuse to and exert cytotoxic effects on neighboring CD30(-) cells, enhancing the overall antitumor activity of SGN-35 in mixed tumor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Okeley, NM., Miyamoto, JB., Zhang, X., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06254495

NCT06254495 | A Safety Study of PF-08046044/SGN-35C ... This study will test the safety of SGN-35C in participants with lymphoma. It will also study the side effects of this drug.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025022074

HL-998: First-in-Human, Open-Label, Phase 1 Study of ... 35C demonstrated promising antitumor activity in heavily pretreated R/R cHL patients who progressed after prior BV and PD-1 inhibitors, as well as in R/R PTCL ...

3. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4160939/christina.poh.first-in-human.open-label.phase.1.study.of.cd30-directed.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D2%2Asearch%3Dchimeric

FIRST-IN-HUMAN, OPEN-LABEL, PHASE 1 STUDY OF ... Updated safety, efficacy and PK data will be presented. Summary/Conclusion: 35C demonstrated promising antitumor activity in heavily pretreated R/R cHL pts ...

4. vjhemonc.com vjhemonc.com/video/ycmosd6dbyw-phase-i-trial-of-sgn-35c-a-novel-cd30-directed-antibody-drug-conjugate-in-rr-lymphomas/

EHA 2025 | Phase I trial of SGN-35C, a novel CD30-directed ... SGN35C with its novel mechanism and favorable safety profile shows early signs of clinical activity even in heavily pre-treated patients.

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06254495

A Safety Study of PF-08046044/SGN-35C in Adults ... 1674.1 - Trial in Progress: Open-Label Phase 1 Study to Evaluate Safety of SGN-35C in Adults with Select Relapsed/Refractory Lymphomas (SGN35C-001). EHA 2024 ...

6. allclinicaltrials.com allclinicaltrials.com/study/NCT06254495

A Safety Study of PF-08046044/SGN-35C in Adults With ... This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection.