A Study of SGN-CD228A in Advanced Solid Tumors

A Phase 1 Study of SGN-CD228A in Select 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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Non-small Cell Lung Cancer; Pancreatic Ductal Adenocarcinoma; Cutaneous Melanoma; Pleural Mesothelioma; HER2 Negative Breast Neoplasms
• Intervention / Treatment: Drug: SGN-CD228A

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy
• Italy
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
• United Kingdom
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Hospital (Surrey)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center / Wake Forest University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University / University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center / University of Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGN-CD228A; SGN-CD228A monotherapy	Drug: SGN-CD228A; SGN-CD228A administered into the vein (IV; intravenously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Any 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 abnormalities		Up to approximately 3.5 years
Number of participants with dose limiting toxicities		Up to approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		Up 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 response	Defined 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 MMAE		Up to approximately 3.5 years
Cmax of total antibody		Up to approximately 3.5 years
Time to maximum concentration (Tmax) of acMMAE		Up to approximately 3.5 years
Tmax of free MMAE		Up to approximately 3.5 years
Tmax of total antibody		Up to approximately 3.5 years
Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE		Up to approximately 3.5 years
AUC(0-last) of free MMAE		Up to approximately 3.5 years
AUC(0-last) of total antibody		Up to approximately 3.5 years
Trough concentration (Ctrough) of acMMAE		Up to approximately 3.5 years
Ctrough of free MMAE		Up to approximately 3.5 years
Ctrough of total antibody		Up to approximately 3.5 years
Incidence of anti-drug antibodies (ADA)		Up to approximately 3.5 years

Collaborators and Investigators

• Sponsor: Seagen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Seattle Genetics; HER2-negative breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Adenoma; Neoplasms, Mesothelial; Breast Neoplasms; Mesothelioma
• Other Study ID Numbers: SGN228-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No