236 Participants Needed

SGN-B7H4V for Advanced Cancers

Recruiting at 45 trial locations
ST
Overseen BySeagen Trial Information Support
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called SGN-B7H4V for safety and side effects in patients with advanced or metastatic solid tumors. It aims to find the right dosage and see if the drug can effectively treat their cancer.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it is common for clinical trials to have specific requirements, so it's best to discuss your current medications with the trial coordinators.

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.

What data supports the idea that SGN-B7H4V for Advanced Cancers is an effective treatment?

The available research shows that targeting B7-H4, which is part of the SGN-B7H4V treatment, can help the body's immune system fight cancer more effectively. Studies have found that blocking B7-H4 can restore the body's natural ability to attack cancer cells, especially in ovarian cancer. This is because B7-H4 is found in high levels in many tumors and is linked to aggressive cancer behavior. By using antibodies to block B7-H4, researchers have been able to improve the immune response against tumors, suggesting that SGN-B7H4V could be an effective treatment for advanced cancers.12345

What data supports the effectiveness of the drug SGN-B7H4V for advanced cancers?

Research suggests that targeting B7-H4, a protein found on tumor cells, can help the immune system fight cancer by restoring T-cell responses that attack tumors. This indicates that drugs like SGN-B7H4V, which target B7-H4, may be effective in treating cancers by enhancing the body's immune response against tumor cells.12345

What safety data is available for SGN-B7H4V in advanced cancers?

The provided research does not contain specific safety data for SGN-B7H4V or its evaluations under different names. The studies listed focus on other treatments and their safety profiles in various cancer types.678910

Is the drug SGN-B7H4V a promising treatment for advanced cancers?

Yes, SGN-B7H4V is a promising treatment for advanced cancers because it targets B7-H4, a protein that can help tumors grow by weakening the immune system. By blocking B7-H4, SGN-B7H4V may help the immune system fight cancer more effectively.1341112

How is the drug SGN-B7H4V different from other cancer treatments?

SGN-B7H4V is unique because it targets B7-H4, a protein that negatively regulates the immune system's response to tumors. By blocking B7-H4, this drug aims to enhance the body's ability to fight cancer, which is a novel approach compared to traditional treatments that may not specifically target this immune checkpoint.1341112

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with advanced solid tumors that are locally advanced, unresectable, or metastatic. Participants must be in good physical condition (ECOG 0 or 1), have measurable disease, and provide tumor tissue. Those with recent other cancers, brain metastases, previous similar treatments, significant neuropathy, or active corneal disease can't join.

Inclusion Criteria

My condition has not improved with standard treatments or I cannot tolerate them.
I have a specific type of advanced or metastatic cancer.
I can provide a sample of my tumor for the study.
See 2 more

Exclusion Criteria

My cancer has spread to the lining of my brain and spinal cord.
My brain metastases are stable, and I haven't taken corticosteroids for them in the last 7 days.
I have not had any other cancers in the last 3 years, or if I have, they are not likely to spread.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A and B

Determine the appropriate dosage of Felmetatug Vedotin for participants

8-12 weeks

Treatment Part C

Evaluate the safety and efficacy of Felmetatug Vedotin in treating solid tumor cancers

12-16 weeks

Treatment Part D

Determine the dosage of Felmetatug Vedotin in combination with pembrolizumab

8-12 weeks

Treatment Part E

Evaluate the safety and efficacy of Felmetatug Vedotin with pembrolizumab in treating triple negative breast cancer

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

  • SGN-B7H4V
Trial OverviewSGN-B7H4V is being tested for safety and effectiveness in treating various solid tumors. The study has three parts: determining the right dose (Parts A & B) and then assessing its safety and how well it works at that dose (Part C).
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Felmetatug Vedotin and Pembrolizumab (Parts D and E)Experimental Treatment2 Interventions
Felmetatug Vedotin in combination with Pembrolizumab.
Group II: Felmetatug Vedotin (Parts A, B, and C)Experimental Treatment1 Intervention
Felmetatug Vedotin monotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials
20
Recruited
4,900+

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 profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Findings from Research

In a study of 408 head and neck squamous cell carcinoma (HNSCC) samples, strong expression of the protein B7-H3 was linked to better overall survival, particularly in patients with p16-negative oropharyngeal SCC, suggesting a potential protective role.
Conversely, the expression of B7-H4 and mRNA levels of both B7-H3 and B7-H4 did not show significant associations with patient survival, indicating that B7-H3 may have a unique prognostic value in this cancer type.
The prognostic impact of B7-H3 and B7-H4 in head and neck squamous cell carcinoma.Borgmann, M., Oetting, A., Meyer, F., et al.[2023]
B7-H4 is expressed on primary ovarian cancer cells and tumor-associated macrophages in vivo, but is quickly lost in established cell lines, indicating its potential role in immune evasion by tumors.
Antibodies targeting B7-H4 can reverse the inhibition of T-cell activation caused by B7-H4+ tumor cells, suggesting that blocking B7-H4 interactions may be an effective therapeutic strategy for enhancing antitumor immune responses in ovarian cancer.
Novel recombinant human b7-h4 antibodies overcome tumoral immune escape to potentiate T-cell antitumor responses.Dangaj, D., Lanitis, E., Zhao, A., et al.[2022]
B7-H4 is identified as a promising therapeutic target in cancer treatment due to its high expression in various tumors, which correlates with more aggressive disease and poorer clinical outcomes.
Blocking B7-H4 may enhance anti-tumor immune responses by reducing the suppression of CD4+ T-cell activity and altering the tumor microenvironment, potentially leading to better clearance of tumor cells.
Potential targeting of B7-H4 for the treatment of cancer.Podojil, JR., Miller, SD.[2022]

References

The prognostic impact of B7-H3 and B7-H4 in head and neck squamous cell carcinoma. [2023]
Novel recombinant human b7-h4 antibodies overcome tumoral immune escape to potentiate T-cell antitumor responses. [2022]
Potential targeting of B7-H4 for the treatment of cancer. [2022]
Isolation and Validation of Anti-B7-H4 scFvs from an Ovarian Cancer scFv Yeast-Display Library. [2015]
Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. [2019]
Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors. [2022]
Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study. [2021]
A phase I trial to determine the safety, pharmacokinetics, and pharmacodynamics of intercalated BMS-690514 with paclitaxel/carboplatin (PC) in advanced or metastatic solid malignancies. [2015]
Controlling tumor invasion: bevacizumab and BMP4 for glioblastoma. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
B7-H4 is a positive regulator of antitumor immunity. [2022]
Serum B7-H4 expression is a significant prognostic indicator for patients with gastric cancer. [2022]