What side effects are associated with this type of intervention?

Common treatments for endometrial cancer include radiation therapy (RT), chemotherapy, and targeted therapies. Radiation therapy can cause acute toxicity, including fatigue, urinary and bowel symptoms, and late toxicity such as long-term urinary and bowel issues. Chemotherapy, such as paclitaxel and carboplatin, can lead to side effects like neurotoxicity, fatigue, and increased risk of infections. Targeted therapies, similar to SGN-B7H4V, which are often antibody-drug conjugates, may cause side effects such as infusion reactions, fatigue, nausea, and potential organ-specific toxicities depending on the target. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

While there is no specific mention of FDA-approved antibody-drug conjugates targeting B7-H4 for endometrial cancer in the provided context, similar targeted therapies have been explored in other cancers. For instance, Sacituzumab Govitecan, an antibody-drug conjugate targeting TROP-2, has been approved for triple-negative breast cancer and is being considered for hormone receptor-positive, HER2-negative breast cancer. Additionally, Tisotumab vedotin, another antibody-drug conjugate, has been approved for recurrent or metastatic cervical cancer. These examples illustrate the potential of targeted therapies and antibody-drug conjugates in treating various cancers, which may be relevant to the ongoing study of SGN-B7H4V in solid tumors.

What other types of research exist?

Promising alternatives to SGN-B7H4V for endometrial cancer patients include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various solid tumors including endometrial cancer. 2) Bevacizumab, an angiogenesis inhibitor, which has been used in combination with chemotherapy for various gynecologic cancers. 3) CD70-targeted antibody-drug conjugates, such as those being studied for uterine leiomyosarcoma, which may have potential in endometrial cancer. 4) PARP inhibitors, particularly for patients with BRCA mutations or homologous recombination deficiency (HRD).

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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 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events (AEs)

Secondary study objectives

Complete response rate (CRR)

Confirmed objective response rate (ORR) by investigator assessment

Duration of response (DOR)

+8 more

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468

100%

PAIN IN EXTREMITY

67%

HEADACHE

67%

PLATELET COUNT DECREASED

67%

COUGH

67%

SORE THROAT

67%

CONSTIPATION

33%

BACK PAIN

33%

NON-CARDIAC CHEST PAIN

33%

DYSPEPSIA

33%

NEUTROPHIL COUNT DECREASED

33%

EYE DISORDERS - OTHER, SPECIFY

33%

DIZZINESS

33%

DYSPNEA

33%

CHRONIC KIDNEY DISEASE

33%

ORAL PAIN

33%

MYALGIA

33%

PNEUMONITIS

33%

GASTROINTESTINAL DISORDERS - OTHER, SPECIFY

33%

PROTEINURIA

33%

ALLERGIC RHINITIS

33%

FATIGUE

33%

ESOPHAGEAL INFECTION

33%

SINUS PAIN

33%

DIARRHEA

33%

ANOREXIA

33%

HYPERGLYCEMIA

33%

DEPRESSION

33%

GINGIVAL PAIN

33%

NAUSEA

33%

RECURRENT LARYNGEAL NERVE PALSY

33%

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY

33%

CHEST WALL PAIN

33%

EDEMA LIMBS

33%

ABDOMINAL PAIN

100%

80%

60%

40%

20%

Study treatment Arm

Imprime PGG 2 mg/kg

Imprime PGG 4 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SGN-B7H4V and Pembrolizumab (Parts D and E)Experimental Treatment2 Interventions

SGN-B7H4V in combination with Pembrolizumab.

Group II: SGN-B7H4V (Parts A, B, and C)Experimental Treatment1 Intervention

SGN-B7H4V monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 7Eligibility criteria met

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.