Back to resultsA Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Primary Purpose
Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGN-BB228
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Melanoma focused on measuring NSCLC, Colorectal Cancer, CRC, Pancreatic Cancer, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
- All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
Participants must have one of the following tumor types:
- Parts A and B: Participants must have unresectable cutaneous melanoma.
Part C: Participants must have one of the following tumor types:
- Cutaneous Melanoma
- Non-small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Cancer
- Mesothelioma
For participants with cutaneous melanoma
- Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
- Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
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.
Active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are:
- clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
- they have no new or enlarging brain metastases,
- and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
- Prior therapies cannot include any drugs targeting CD228 or 4-1BB
- Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
Sites / Locations
- University of California at San FranciscoRecruiting
- Sarah Cannon Research Institute at HealthONE - DenverRecruiting
- Northwestern UniversityRecruiting
- Massachusetts General HospitalRecruiting
- Dana Farber Cancer InstituteRecruiting
- NYU Langone HospitalRecruiting
- Duke University Medical CenterRecruiting
- Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of WashingtonRecruiting
- Universitatsspital ZurichRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-BB228
Arm Description
SGN-BB228 monotherapy
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs)
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
Number of participants with antidrug antibodies
To be summarized using descriptive statistics
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics
PK parameter - Maximum Concentration (Cmax)
To be summarized using descriptive statistics
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Objective response rate (ORR)
The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause
Progression-free survival (PFS)
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause
Overall survival (OS)
The time from the start of study treatment to death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05571839
Brief Title
A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Official Title
A Phase 1 Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)
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 study will test the safety of a drug called SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.
This study will have 3 parts. Parts A and B of the study will find out how much SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if SGN-BB228 is safe and if it works to treat solid tumor cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms, Mesothelioma
Keywords
NSCLC, Colorectal Cancer, CRC, Pancreatic 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
275 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGN-BB228
Arm Type
Experimental
Arm Description
SGN-BB228 monotherapy
Intervention Type
Drug
Intervention Name(s)
SGN-BB228
Intervention Description
Given into the vein (IV; intravenous)
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
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
Through 30 days after the last study treatment; approximately 7 months
Title
Number of participants with laboratory abnormalities
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
Number of participants with dose limiting toxicities
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Number of participants with antidrug antibodies
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
PK parameter - Maximum Concentration (Cmax)
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
PK parameter - Time to maximum concentration (Tmax)
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
PK parameter - Apparent terminal half-life (t1/2)
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
PK parameter - Trough concentration (Ctrough)
Description
To be summarized using descriptive statistics
Time Frame
Through 30 days after the last study treatment; approximately 7 months
Title
Objective response rate (ORR)
Description
The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator
Time Frame
Up to approximately 1 year
Title
Duration of response (DOR)
Description
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause
Time Frame
Up to approximately 1 year
Title
Progression-free survival (PFS)
Description
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause
Time Frame
Up to approximately 1 year
Title
Overall survival (OS)
Description
The time from the start of study treatment to death due to any cause
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy.
Participants must have one of the following tumor types:
Parts A and B: Participants must have unresectable cutaneous melanoma.
Part C: Participants must have one of the following tumor types:
Cutaneous Melanoma
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Cancer
Mesothelioma
For participants with cutaneous melanoma
Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies.
Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Measurable disease per RECIST v1.1 at baseline
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.
Active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are:
clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
they have no new or enlarging brain metastases,
and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug.
Prior therapies cannot include any drugs targeting CD228 or 4-1BB
Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seagen Trial Information Support
Phone
866-333-7436
Email
clinicaltrials@seagen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M. Pinelli, PA-C, MMSc
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeremy Sauer, PhD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namrata Shetty
First Name & Middle Initial & Last Name & Degree
Adil Daud, MD
Facility Name
Sarah Cannon Research Institute at HealthONE - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Henry
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Backlund
Phone
312-695-8680
Email
Alexandra.backlund@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Sunandana Chandra
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamaneh Montazeri
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Hodi
Facility Name
NYU Langone Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirly Gholian
Phone
212-731-6262
First Name & Middle Initial & Last Name & Degree
Janice Mehnert
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Salama
Facility Name
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Tachiki, MD
Facility Name
Universitatsspital Zurich
City
Zurich
State/Province
Other
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors
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