Back to resultsA Study of SGN-CD228A in Advanced Solid Tumors
Primary Purpose
Cutaneous Melanoma, Pleural Mesothelioma, HER2 Negative Breast Neoplasms
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGN-CD228A
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Melanoma focused on measuring HER2-negative breast cancer, Seattle Genetics
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
Sites / Locations
- University of Alabama at Birmingham
- The Angeles Clinic and Research Institute
- University of Chicago Medical Center
- Wake Forest Baptist Medical Center / Wake Forest University
- Case Western Reserve University / University Hospitals Cleveland Medical Center
- Oregon Health and Science University
- University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
- Sanford Cancer Center
- MD Anderson Cancer Center / University of Texas
- South Texas Accelerated Research Therapeutics
- Institut Gustave Roussy
- Istituto Europeo di Oncologia
- Hospital Universitario Vall d'Hebron
- The Royal Marsden Hospital (Surrey)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-CD228A
Arm Description
SGN-CD228A monotherapy
Outcomes
Primary Outcome Measures
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.
Number of participants with laboratory abnormalities
Number of participants with dose limiting toxicities
Secondary Outcome Measures
Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)
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.
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.
Overall survival (OS)
Defined as the time from the start of any study treatment to the date of death due to any cause.
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.
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.
Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)
Cmax of free MMAE
Cmax of total antibody
Time to maximum concentration (Tmax) of acMMAE
Tmax of free MMAE
Tmax of total antibody
Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE
AUC(0-last) of free MMAE
AUC(0-last) of total antibody
Trough concentration (Ctrough) of acMMAE
Ctrough of free MMAE
Ctrough of total antibody
Incidence of anti-drug antibodies (ADA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04042480
Brief Title
A Study of SGN-CD228A in Advanced Solid Tumors
Official Title
A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to portfolio prioritization
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Pleural Mesothelioma, HER2 Negative Breast Neoplasms, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Keywords
HER2-negative breast cancer, Seattle Genetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGN-CD228A
Arm Type
Experimental
Arm Description
SGN-CD228A monotherapy
Intervention Type
Drug
Intervention Name(s)
SGN-CD228A
Intervention Description
SGN-CD228A administered into the vein (IV; intravenously)
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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.
Time Frame
Up to approximately 3.5 years
Title
Number of participants with laboratory abnormalities
Time Frame
Up to approximately 3.5 years
Title
Number of participants with dose limiting toxicities
Time Frame
Up to approximately 3.5 years
Secondary Outcome Measure Information:
Title
Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
Up to approximately 3.5 years
Title
Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)
Time Frame
Up to approximately 3.5 years
Title
Objective response rate (ORR)
Description
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.
Time Frame
Up to approximately 3.5 years
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to approximately 3.5 years
Title
Overall survival (OS)
Description
Defined as the time from the start of any study treatment to the date of death due to any cause.
Time Frame
Up to approximately 3.5 years
Title
Duration of objective response (DOR)
Description
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.
Time Frame
Up to approximately 3.5 years
Title
Duration of complete response
Description
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.
Time Frame
Up to approximately 3.5 years
Title
Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)
Time Frame
Up to approximately 3.5 years
Title
Cmax of free MMAE
Time Frame
Up to approximately 3.5 years
Title
Cmax of total antibody
Time Frame
Up to approximately 3.5 years
Title
Time to maximum concentration (Tmax) of acMMAE
Time Frame
Up to approximately 3.5 years
Title
Tmax of free MMAE
Time Frame
Up to approximately 3.5 years
Title
Tmax of total antibody
Time Frame
Up to approximately 3.5 years
Title
Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE
Time Frame
Up to approximately 3.5 years
Title
AUC(0-last) of free MMAE
Time Frame
Up to approximately 3.5 years
Title
AUC(0-last) of total antibody
Time Frame
Up to approximately 3.5 years
Title
Trough concentration (Ctrough) of acMMAE
Time Frame
Up to approximately 3.5 years
Title
Ctrough of free MMAE
Time Frame
Up to approximately 3.5 years
Title
Ctrough of total antibody
Time Frame
Up to approximately 3.5 years
Title
Incidence of anti-drug antibodies (ADA)
Time Frame
Up to approximately 3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Gupta, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Wake Forest Baptist Medical Center / Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Case Western Reserve University / University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sanford Cancer Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
The Royal Marsden Hospital (Surrey)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of SGN-CD228A in Advanced Solid Tumors
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