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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study 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.

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

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
68,798 Total Patients Enrolled
3 Trials studying Endometrial Cancer
233 Patients Enrolled for Endometrial Cancer
Natalya Nazarenko, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
824 Total Patients Enrolled
JoAl Mayor, PharmD, BCOPStudy DirectorSeagen Inc.
5 Previous Clinical Trials
272 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

Frequently Asked Questions

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

What is the scope of facilities participating in this research project?

"Ten clinics are offering this clinical trial, including Sarah Cannon Research Institute at HealthONE - Denver in Denver, Mayo Clinic Florida in Jacksonville, and Community Health Network in Indianapolis. Seven other medical centres have also been tapped for patient recruitment."

Answered by AI

What are the primary objectives of this investigation?

"This study, which will be followed for up to three years, seeks to determine the number of participants who experience dose-limiting toxicities. The secondary goals include measuring progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) within a 30-37 day period after last treatment."

Answered by AI

How many participants are actively involved in this clinical investigation?

"Affirmative. In accordance with the data hosted on clinicaltrials.gov, this study is actively recruiting patients and has been since 1/12/2022; it was last updated in November 11th 2022. 375 individuals are needed to be enrolled from 10 different sites."

Answered by AI

What is the known risk profile of SGN-B7H4V for patients?

"Our team at Power has gauged the safety of SGN-B7H4V as a 1, reflecting its Phase 1 status. This implies that only minimal data exists to support efficacy and security protocols."

Answered by AI

Are there any opportunities for participation in this experiment currently available?

"Affirmative. Clinicaltrials.gov records reveal that this medical trial, launched on December 1st 2022, is presently recruiting participants. The study seeks 375 volunteers across 10 distinct clinical sites."

Answered by AI
~147 spots leftby Jun 2025