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SGN-B7H4V for Breast Cancer

MD Anderson Cancer Center / University of Texas, Houston, TX
Breast Cancer+11 More ConditionsSGN-B7H4V - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • HER2-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Gallbladder Cancer
  • Hormone Receptor-positive Breast Cancer
  • Endometrial Cancer
  • Peritoneal Tumors
  • Non-Small Cell Lung Cancer
  • Adenoid Cystic Carcinoma
  • Fallopian Tube Cancer
  • Bile Duct Cancer
  • Triple Negative Breast Cancer
  • Ovarian Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
AL101
1
SGN-ALPV
1
XMT-1660

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Up to approximately 3 years

Year 3
Number of participants with adverse events (AEs)
Year 3
Incidence of antidrug antibodies (ADAs)
Number of participants with laboratory abnormalities
PK parameter - Apparent terminal half-life (t1/2)
PK parameter - Maximum concentration (Cmax)
PK parameter - Time to maximum concentration (Tmax)
PK parameter - Trough concentration (Ctrough)
Year 3
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Up to 28 days
Number of participants with dose limiting toxicities (DLTs)
Year 3
Complete response rate (CRR)
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
AL101
1
SGN-ALPV
1
XMT-1660

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

SGN-B7H4V
1 of 1

Experimental Treatment

400 Total Participants · 1 Treatment Group

Primary Treatment: SGN-B7H4V · No Placebo Group · Phase 1

SGN-B7H4V
Drug
Experimental Group · 1 Intervention: SGN-B7H4V · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
190 Previous Clinical Trials
65,345 Total Patients Enrolled
6 Trials studying Breast Cancer
3,414 Patients Enrolled for Breast Cancer
Natalya Nazarenko, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
572 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Parts A and B: You have a medical condition that has already been treated with standard-of-care therapies but your condition has not improved or has worsened. Your doctor has determined that there are no other treatment options available for you. Part C: You have a medical condition that has already been treated with standard-of-care therapies but your condition has not improved or has worsened, unless your doctor has reasons to not use these therapies.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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