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Monoclonal Antibodies

Disitamab Vedotin for Solid Tumors

Providence Medical Foundation, Santa Rosa, CA

Targeting 4 different conditionsdisitamab vedotinPhase 2RecruitingResearch Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

- Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin

- Must have pathologically documented adenocarcinoma of the endometrium

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upapproximately 5 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial tests a drug to see if it works to treat advanced solid tumors with HER2. It also looks at safety and side effects.

Eligible Conditions

Ovarian Tumors
Endometrial Cancer
Squamous Cell Carcinoma
Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Your cancer cannot be surgically removed and has spread to other parts of your body.

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This study is specifically for people with ovarian cancer.

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You have cancer that cannot be removed through surgery and has either spread to other parts of the body or is in an advanced stage.

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You have previously received a type of treatment called anti-PD(L)1 therapy.

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This study is specifically looking for participants with head and neck squamous cell carcinoma (HNSCC).

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You have already received chemotherapy with platinum-based drugs for your advanced or recurring cancer, but it did not work or your condition got worse.

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Your cancer has spread to other parts of your body and cannot be removed by surgery.

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You have not shown improvement in your condition after receiving a certain type of chemotherapy called platinum-based therapy.

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Your cancer is in an advanced stage and cannot be removed through surgery.

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You have previously received a specific type of immunotherapy called anti-PD(L)1 therapy.

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This study is not meant for people with endometrial cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Duration of Progression Free Survival (PFS) per RECIST v1.1 by investigator assessment

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

+8 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

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

202 Previous Clinical Trials

68,225 Total Patients Enrolled

Xuemei LiStudy DirectorSeagen Inc.

1 Previous Clinical Trials

750 Total Patients Enrolled

Frequently Asked Questions

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

Are there still spots available in this medical trial?

"Confirmation on clinicaltrials.gov reveals that participant recruitment for this trial is ongoing and the study was originally posted to the website on November 30th 2023, with its most recent update being made September 15th 2023."

Answered by AI

Has the Disitamab vedotin single-drug approach gained regulatory approval?

"The safety profile of Disitamab vedotin monotherapy is assessed a 2 as there are some data points suggesting its relative security, but no evidence has been collected to verify its efficacy."

Answered by AI

How many distinct sites are carrying out this research?

"At this moment, 4 trial sites are operational and actively taking on new participants. Norwich, Canton, El Paso will be the most accessible for many people; however other locations exist if that is more convenient."

Answered by AI

How many individuals have thus far enrolled in this experiment?

"Affirmative, clinicaltrials.gov indicates that this research is actively engaging patients to take part in the experiment. It was initially posted on November 30th 2023 and has since been revised as of September 15th 2023. This trial needs 190 individuals across 4 sites for full enrollment completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

2023. "A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003231.

All > Non Small Cell Lung Cancer > Endometrial Cancer