What side effects are associated with this type of intervention?

Common treatments for ovarian tumors include chemotherapy agents like carboplatin, paclitaxel, and bevacizumab, as well as targeted therapies such as antibody-drug conjugates (ADCs). The side effects of these treatments can vary. Chemotherapy often causes nausea, vomiting, hair loss, and myelosuppression. Bevacizumab, an angiogenesis inhibitor, can lead to hypertension, proteinuria, and increased risk of bleeding. ADCs, like Disitamab Vedotin, typically cause side effects such as fatigue, peripheral neuropathy, and gastrointestinal issues like diarrhea. These treatments aim to target cancer cells more precisely, but they still carry a risk of significant adverse effects.

What prior FDA approvals exist?

FDA approvals for the treatment of ovarian tumors have included various targeted therapies and chemotherapeutic agents. While specific antibody-drug conjugates (ADCs) targeting HER2 like Disitamab Vedotin are not mentioned, other targeted therapies such as bevacizumab (an anti-VEGF monoclonal antibody) and PARP inhibitors like olaparib have been approved for ovarian cancer. These treatments focus on specific molecular targets to inhibit tumor growth and progression. Broadly, the treatment landscape for ovarian tumors includes a combination of surgery, chemotherapy, and targeted therapies, with ongoing research into novel agents like ADCs to improve outcomes.

What other types of research exist?

Promising alternatives to Disitamab Vedotin for ovarian tumors include Bevacizumab, an angiogenesis inhibitor used in combination with platinum-based chemotherapy and as maintenance therapy, and PARP inhibitors like Olaparib, which are used for maintenance therapy in platinum-sensitive recurrent ovarian cancer. Additionally, other ADCs and novel agents targeting HER2 or similar pathways may also be considered based on emerging clinical trial data.

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Monoclonal Antibodies

Disitamab Vedotin for HER2-Positive Cancer

Phase 2

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called disitamab vedotin (DV) on patients with advanced or metastatic cancers that have a specific marker called HER2. The drug works by finding and attaching to cancer cells, then delivering a substance to kill them. The study aims to see if DV is effective and safe for these patients. Disitamab vedotin is an antibody-drug conjugate designed for targeting HER2 that has been approved for urothelial carcinoma and gastric cancer.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors like head and neck, lung, endometrial, or ovarian cancer that have a HER2 marker. They must have tried platinum-based therapy without success and can't have had too many prior treatments. People with untreated brain metastases, previous HER2-targeted ADC treatment, recent other cancers, or sensitivity to DV ingredients cannot join.

What is being tested?

The study tests disitamab vedotin (DV), an experimental antibody-drug conjugate designed to target and kill cancer cells in tumors expressing the HER2 marker. Participants will receive DV every two weeks to evaluate its effectiveness against various solid tumors and assess its safety profile.

What are the potential side effects?

Potential side effects of DV include reactions at the infusion site, possible damage to healthy cells leading to fatigue, nausea or hair loss among others. The trial aims to document all adverse effects experienced by participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

Secondary study objectives

Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment

Duration of Response (DOR) per RECIST v1.1 by investigator assessment

Number of participants with adverse events (AEs)

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Disitamab vedotin monotherapyExperimental Treatment1 Intervention

Disitamab vedotin monotherapy

Do I qualify?Apply below to find out

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 ovarian tumors include antibody-drug conjugates (ADCs) like Disitamab Vedotin, which target specific markers such as HER2 on cancer cells and deliver cytotoxic agents directly to them. This targeted approach helps minimize damage to healthy tissues. Other treatments include chemotherapy, which kills rapidly dividing cells, and targeted therapies like PARP inhibitors and angiogenesis inhibitors, which disrupt cancer cell DNA repair and blood vessel formation, respectively. Understanding these mechanisms is crucial for selecting the most effective treatment, improving outcomes, and reducing side effects for ovarian tumor patients.

Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.