Breast Cancer Clinical Trial

A Study of SGN-PDL1V in Advanced Solid Tumors

Summary

This study will test the safety of a drug called SGN-PDL1V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have three parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Parts A and B:

Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types

Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC)
Esophageal squamous cell carcinoma (SCC)
Triple negative breast cancer (TNBC)
Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option

Part C:

Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types

HNSCC

Participants with HNSCC must have histologically or cytologically-confirmed SCC of the head and neck
NSCLC
Esophageal SCC
Ovarian cancer
Melanoma
TNBC
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.

Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:

Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
Have no new or enlarging brain metastases
And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
Lepto-meningeal disease
Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

315

Study ID:

NCT05208762

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 6 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Kerstin Hetzler
Contact
205-934-5790
[email protected]
Lisle Nabell
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jadi Bohac
Contact
713-794-5454
[email protected]
Maura Gillison
Principal Investigator
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Isabel Jimenez
Contact
210-593-5265
[email protected]
Amita Patnaik
Principal Investigator
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City Utah, 84119, United States More Info
Marianne Herndon
Contact
801-907-4753
[email protected]
Justin Call
Principal Investigator
NEXT Oncology
Fairfax Virginia, 22031, United States More Info
Maryanne Poole
Contact
703-280-5390
[email protected]
Alexander Spira
Principal Investigator
University Health Network, Princess Margaret Hospital
Toronto , M5G 2, Canada More Info
Anna Spreafico
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

315

Study ID:

NCT05208762

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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