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PD-L1 Inhibitor

SGN-PDL1V for Cancer

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

Be older than 18 years old

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 for solid tumors. It will also study side effects. The study has three parts and will enroll participants who have metastatic or unresectable solid tumors.

Who is the study for?

This trial is for adults with certain advanced solid tumors like lung, breast, esophageal cancer or melanoma that have spread and can't be surgically removed. Participants must have tried standard treatments without success or cannot tolerate them. They should be relatively active and well (ECOG score of 0 or 1) and not have had specific recent cancers, brain metastases, severe neuropathy, or treatment with similar drugs.Check my eligibility

What is being tested?

SGN-PDL1V is being tested to determine its safety and effectiveness in treating various types of advanced solid tumors. The study has three parts: Parts A and B will decide the right dose; Part C will test this dose further for safety outcomes and how well it works against the cancer.See study design

What are the potential side effects?

While the exact side effects are being studied, potential ones may include typical reactions to cancer therapy such as fatigue, nausea, inflammation-related symptoms due to immune response modulation by SGN-PDL1V, as well as any unexpected effects on organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

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 DLTs by dose level

Number of participants with adverse events (AEs)

Number of participants with dose-limiting toxicities (DLTs)

+1 more

Secondary outcome measures

Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment

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

Incidence of anti-drug antibodies (ADAs)

+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Group I: SGN-PDL1V MonotherapyExperimental Treatment1 Intervention

SGN-PDL1V monotherapy

Group II: SGN-PDL1V Combination TherapyExperimental Treatment2 Interventions

SGN-PDL1V + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

207 Previous Clinical Trials

68,835 Total Patients Enrolled

Andres Forero-Torres, MDStudy DirectorSeagen Inc.

3 Previous Clinical Trials

227 Total Patients Enrolled

Media Library

SGN-PDL1V (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05208762 — Phase 1

Esophageal Cancer Research Study Groups: SGN-PDL1V Monotherapy, SGN-PDL1V Combination Therapy

Esophageal Cancer Clinical Trial 2023: SGN-PDL1V Highlights & Side Effects. Trial Name: NCT05208762 — Phase 1

SGN-PDL1V (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05208762 — Phase 1

Frequently Asked Questions

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

Has the Food and Drug Administration accorded approval to SGN-PDL1V?

"Our team at Power believes that SGN-PDL1V is relatively safe, rating it a 1 on the scale. This assessment is based upon its status as an early phase trial, with limited efficacy and safety data available."

Answered by AI

Are there any locations in North America where this clinical investigation is taking place?

"At present, this clinical trial is enrolling participants at NEXT Oncology in Fairfax, Virginia; The University of Texas MD Anderson Cancer Center in Houston, Texas; and South Texas Accelerated Research Therapeutics in San Antonio, Utah. There are also 5 additional sites offering this medication."

Answered by AI

Is this investigation open to recruitment?

"Affirmative. All information found on clinicaltrials.gov confirms that this medical experiment, which was initially declared on the 25th of October 2022, is still looking for participants. It requires 315 people to join from 5 distinct healthcare centres."

Answered by AI

To what extent are participants engaging in this investigation?

"Affirmative, the information on clinicaltrials.gov reveals that this study is currently seeking individuals to enroll in their trial. Initially posted October 25th 2022 and last modified November 11th 2022, this research needs 315 participants from 5 different sites."

Answered by AI

What therapeutic objectives are the researchers hoping to realize with this clinical trial?

"This study will last approximately one month and its primary outcome is the number of participants with adverse events. Secondary objectives include overall survival, objective response rate per RECIST v1.1 by investigator assessment, and pharmacokinetic parameters such as apparent terminal half-life."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SGN-PDL1V in Advanced Solid Tumors

2022. "A Study of SGN-PDL1V in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208762.

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