A Study of SGN-CD228A in Advanced Solid Tumors

NCT ID: NCT04042480

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2023-03-09

Brief 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.

Detailed 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.

Conditions

Cutaneous Melanoma; Pleural Mesothelioma; HER2 Negative Breast Neoplasms; Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGN-CD228A

SGN-CD228A monotherapy

Group Type: EXPERIMENTAL

SGN-CD228A

Intervention Type: DRUG

SGN-CD228A administered into the vein (IV; intravenously)

Interventions

SGN-CD228A

SGN-CD228A administered into the vein (IV; intravenously)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anu Gupta, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Wake Forest Baptist Medical Center / Wake Forest University

Winston-Salem, North Carolina, United States

Case Western Reserve University / University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Institut Gustave Roussy

Villejuif, , France

Istituto Europeo di Oncologia

Milan, , Italy

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

The Royal Marsden Hospital (Surrey)

Sutton, , United Kingdom

Countries

United States; France; Italy; Spain; United Kingdom

References

Mazahreh R, Mason ML, Gosink JJ, Olson DJ, Thurman R, Hale C, Westendorf L, Pires TA, Leiske CI, Carlson M, Nguyen LT, Cochran JH, Okeley NM, Yumul R, Jin S, Stone IJ, Sahetya D, Nesterova A, Allred S, Hensley KM, Hu R, Lawrence R, Lewis TS, Sandall S. SGN-CD228A Is an Investigational CD228-Directed Antibody-Drug Conjugate with Potent Antitumor Activity across a Wide Spectrum of Preclinical Solid Tumor Models. Mol Cancer Ther. 2023 Apr 3;22(4):421-434. doi: 10.1158/1535-7163.MCT-22-0401.

Reference Type: DERIVED

PMID: 36800443 (View on PubMed)

Other Identifiers

SGN228-001

Identifier Type: -

Identifier Source: org_study_id