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Clinical Trial Record

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A Study of SGN-CD228A in Advanced Solid Tumors

2019-09-03

2023-03-09

2023-03-09

88

Study Overview

A Study of SGN-CD228A in Advanced Solid Tumors

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.

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.

  • Cutaneous Melanoma
  • Pleural Mesothelioma
  • HER2 Negative Breast Neoplasms
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma
  • DRUG: SGN-CD228A
  • SGN228-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-07-31  

N/A  

2023-03-21  

2019-07-31  

N/A  

2023-03-23  

2019-08-02  

N/A  

2023-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: SGN-CD228A

SGN-CD228A monotherapy

DRUG: SGN-CD228A

  • SGN-CD228A administered into the vein (IV; intravenously)
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of participants with adverse eventsAny untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.Up to approximately 3.5 years
Number of participants with laboratory abnormalitiesUp to approximately 3.5 years
Number of participants with dose limiting toxicitiesUp to approximately 3.5 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Up to approximately 3.5 years
Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)Up to approximately 3.5 years
Objective response rate (ORR)A participant is determined to have an OR if they achieve a complete response (CR) or partial response (PR) after initiation of study treatment and at or prior to the end-of-treatment disease assessment.Up to approximately 3.5 years
Progression-free survival (PFS)Defined as the time from the start of study treatment to first documentation of disease progression or death due to any cause, whichever comes first.Up to approximately 3.5 years
Overall survival (OS)Defined as the time from the start of any study treatment to the date of death due to any cause.Up to approximately 3.5 years
Duration of objective response (DOR)Defined as the time from start of the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of confirm tumor progression or death due to any cause, whichever comes first.Up to approximately 3.5 years
Duration of complete responseDefined as the time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first.Up to approximately 3.5 years
Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)Up to approximately 3.5 years
Cmax of free MMAEUp to approximately 3.5 years
Cmax of total antibodyUp to approximately 3.5 years
Time to maximum concentration (Tmax) of acMMAEUp to approximately 3.5 years
Tmax of free MMAEUp to approximately 3.5 years
Tmax of total antibodyUp to approximately 3.5 years
Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAEUp to approximately 3.5 years
AUC(0-last) of free MMAEUp to approximately 3.5 years
AUC(0-last) of total antibodyUp to approximately 3.5 years
Trough concentration (Ctrough) of acMMAEUp to approximately 3.5 years
Ctrough of free MMAEUp to approximately 3.5 years
Ctrough of total antibodyUp to approximately 3.5 years
Incidence of anti-drug antibodies (ADA)Up to approximately 3.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Anu Gupta, MD, Seagen Inc.

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • 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.
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