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Monoclonal Antibodies

SGN-B7H4V for Advanced Cancers

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 must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types: High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; HER2-negative, HR positive breast cancer; Triple-negative breast cancer (TNBC); Endometrial carcinoma; Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC]); Cholangiocarcinoma or gallbladder carcinoma; Adenoid cystic carcinoma (ACC)
Tumor tissue is required for enrollment
Must not have
Carcinomatous meningitis
Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Summary

This trial will test the safety of a new drug, SGN-B7H4V, in patients with solid tumors that have spread and are inoperable or have metastasized. The trial will also study side effects of the drug.

Who is the study for?
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.Check my eligibility
What is being tested?
SGN-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).See study design
What are the potential side effects?
While specific side effects of SGN-B7H4V aren't listed here, they may include any unintended physical response to the drug besides its intended cancer treatment effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific type of advanced or metastatic cancer.
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I can provide a sample of my tumor for the study.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the lining of my brain and spinal cord.
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I do not have severe nerve pain or damage.
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I have a corneal condition that needs treatment or monitoring.
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I have previously been treated with drugs targeting B7-H4 or containing MMAE.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years 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 adverse events (AEs)
Number of participants with dose limiting toxicities (DLTs)
Number of participants with laboratory abnormalities
Secondary outcome measures
Complete response rate (CRR)
Confirmed objective response rate (ORR) by investigator assessment
Duration of response (DOR)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SGN-B7H4VExperimental Treatment1 Intervention
SGN-B7H4V monotherapy

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for endometrial cancer include chemotherapy, hormone therapy, and targeted therapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while hormone therapy blocks hormones that fuel cancer growth. Targeted therapies, such as antibody-drug conjugates like SGN-B7H4V, are designed to specifically target cancer cells with minimal impact on normal cells. SGN-B7H4V targets the B7-H4 protein, which is often overexpressed in cancer cells, delivering a cytotoxic agent directly to the tumor. This precision reduces side effects and improves efficacy, making it a promising option for patients with advanced or metastatic endometrial cancer.
Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Clinical Trials Planning Meeting: taking endometrial cancer trials into the translational era.

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
209 Previous Clinical Trials
73,945 Total Patients Enrolled
3 Trials studying Endometrial Cancer
233 Patients Enrolled for Endometrial Cancer
Medical MonitorStudy DirectorSeagen Inc.
1,672 Previous Clinical Trials
988,038 Total Patients Enrolled
Natalya Nazarenko, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
824 Total Patients Enrolled

Media Library

SGN-B7H4V (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05194072 — Phase 1
Endometrial Cancer Research Study Groups: SGN-B7H4V
Endometrial Cancer Clinical Trial 2023: SGN-B7H4V Highlights & Side Effects. Trial Name: NCT05194072 — Phase 1
SGN-B7H4V (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194072 — Phase 1
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