Breast Cancer Clinical Trial

A Study of SGN-CD228A in Advanced Solid Tumors

Summary

This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

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Full Description

This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available. Disease-specific escalation/expansion includes the following tumor types.

Metastatic cutaneous melanoma(MCM):

Metastatic or advanced cutaneous melanoma, excludes acral or mucosal varieties.
Participants must have received at least 1 PD-1-targeted therapy unless contraindicated.
Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.

Malignant pleural mesothelioma (MPM):

Participants must have received cisplatin and pemetrexed unless contraindicated.

Advanced HER2-negative breast cancer:

Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane.
Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.

Advanced non-small cell lung cancer (NSCLC):

Participants must have locally advanced or metastatic EGFR wild-type NSCLC.
Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy as a single agent or as part of a combination unless contraindicated.

Advanced colorectal cancer:

Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.

Advanced pancreatic ductal adenocarcinoma (PDAC):

Participants must have unresectable or advanced PDAC.
Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.
Participants should be able to provide adequate tumor tissue for biomarker analysis
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion Criteria

History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Pre-existing neuropathy Grade 2 or greater
Retinal or macular disease requiring treatment or ongoing active monitoring
Prior receipt of SGN-CD228A or MMAE-containing agents

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

210

Study ID:

NCT04042480

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 14 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Jamie Rosser
Contact
[email protected]
Aparna Hegde
Principal Investigator
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Saba Mukarram
Contact
310-231-2181
[email protected]
Ani Balmanoukian
Principal Investigator
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Hedy Kindler
Principal Investigator
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem North Carolina, 27157, United States More Info
Amanda Gregson
Contact
336-716-2011
[email protected]
Caio Rocha-Lima
Contact
336-716-2011
[email protected]
Caio Rocha-Lima
Principal Investigator
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Ashley Campbell
Contact
216-844-6088
[email protected]
Afshin Dowlati
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Christine Long
Contact
[email protected]
Shivaani Kummar
Principal Investigator
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Diwakar Davar
Contact
412-647-2811
[email protected]
Kimberly Russell
Contact
[email protected]
Diwakar Davar
Principal Investigator
Sanford Cancer Center
Sioux Falls South Dakota, 57104, United States More Info
Staci Vogel
Contact
605-328-8000
[email protected]
Steven Powell
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Julia Moore
Contact
713-792-5199
[email protected]
Funda Meric-Bernstam
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
Institut Gustave Roussy
Villejuif Cedex , 94805, France More Info
Capucine Baldini
Principal Investigator
Istituto Europeo di Oncologia
Milano , 20141, Italy More Info
Giuseppe Curigliano
Principal Investigator
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain More Info
Elena Garralda Cabanas
Principal Investigator
The Royal Marsden Hospital (Surrey)
Sutton , SM2 5, United Kingdom More Info
Anna Minchom
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

210

Study ID:

NCT04042480

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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