Back to resultsA Study of SGN-PDL1V in Advanced Solid Tumors
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGN-PDL1V
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small cell lung cancer, NSCLC, Head and neck squamous cell carcinoma, HNSCC, Ovarian cancer, Triple Negative Breast Cancer, TNBC, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
Parts A and B:
Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (HNSCC)
- Esophageal squamous cell carcinoma (SCC)
- Triple negative breast cancer (TNBC)
- Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
Part C:
Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
HNSCC
- Participants with HNSCC must have histologically or cytologically-confirmed SCC of the head and neck
- NSCLC
- Esophageal SCC
- Ovarian cancer
- Melanoma
- TNBC
- 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 of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
Known active central nervous system metastases. 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
- Have no new or enlarging brain metastases
- And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
- Lepto-meningeal disease
- Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
- Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
- Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
There are additional inclusion criteria. The study center will determine if criteria for participations are met.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- University of California DavisRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- South Texas Accelerated Research TherapeuticsRecruiting
- South Texas Accelerated Research Therapeutics Mountain RegionRecruiting
- NEXT OncologyRecruiting
- Institut Jules BordetRecruiting
- University Health Network, Princess Margaret HospitalRecruiting
- McGill University Department of Oncology / McGill University Health CentreRecruiting
- Institut CurieRecruiting
- Institut Gustave RoussyRecruiting
- Charite Universitatsmedizin BerlinRecruiting
- Istituto Europeo di OncologiaRecruiting
- Azienda Ospedaliera Universitaria Integrata di VeronaRecruiting
- Antoni Van LeeuwenhoekziekenhuisRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)Recruiting
- Sarah Cannon Research Institute UKRecruiting
- The Royal Marsden HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-PDL1V
Arm Description
SGN-PDL1V 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 (DLTs)
Number of participants with DLTs by dose level
Secondary Outcome Measures
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with a partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by the investigator.
Duration of objective response per RECIST v1.1 by investigator assessment
The time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
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.
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
To be summarized using descriptive statistics
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Incidence of anti-drug antibodies (ADAs)
To be summarized using descriptive statistics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05208762
Brief Title
A Study of SGN-PDL1V in Advanced Solid Tumors
Official Title
A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (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-PDL1V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have three parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is 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
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma, Ovarian Neoplasms, Melanoma, Triple Negative Breast Neoplasms
Keywords
Non-small cell lung cancer, NSCLC, Head and neck squamous cell carcinoma, HNSCC, Ovarian cancer, Triple Negative Breast Cancer, TNBC, 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
315 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGN-PDL1V
Arm Type
Experimental
Arm Description
SGN-PDL1V monotherapy
Intervention Type
Drug
Intervention Name(s)
SGN-PDL1V
Intervention Description
Given into the vein (IV; intravenously)
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 approximately 90 days after last study treatment; up to 3 years
Title
Number of participants with laboratory abnormalities
Time Frame
Through approximately 90 days after last study treatment; up to 3 years
Title
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
Through the first cycle of study treatment; approximately 1 month
Title
Number of participants with DLTs by dose level
Time Frame
Through the first cycle of study treatment; approximately 1 month
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
Description
The proportion of participants with a partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by the investigator.
Time Frame
Up to approximately 3 years
Title
Duration of objective response per RECIST v1.1 by investigator assessment
Description
The time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Time Frame
Up to approximately 3 years
Title
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
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 3 years
Title
Overall survival (OS)
Description
The time from the start of study treatment to death due to any cause.
Time Frame
Up to approximately 3 years
Title
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Title
PK parameter - Maximum concentration (Cmax)
Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Title
PK parameter - Trough concentration (Ctrough)
Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Title
Incidence of anti-drug antibodies (ADAs)
Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parts A and B:
Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC)
Esophageal squamous cell carcinoma (SCC)
Triple negative breast cancer (TNBC)
Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
Participants must have PD-L1 expression based on historical testing
Part C:
Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
HNSCC
Participants with HNSCC must have histologically or cytologically-confirmed SCC of the head and neck
NSCLC
Esophageal SCC
Ovarian cancer
Melanoma
TNBC
Participants must have PD-L1 expression based on historical testing
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 of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
Known active central nervous system metastases. 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
Have no new or enlarging brain metastases
And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
Lepto-meningeal disease
Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
There are additional inclusion criteria. The study center will determine if criteria for participations are met.
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
Andres Forero-Torres, 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
35294-3300
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Hetzler
Phone
(+1)-205-934-5790
Email
khetzler@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Lisle Marie Nabell
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Lara
Phone
916-734-8134
Email
fnlara@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Jonathan W Riess
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Boland
Phone
216-286-3369
Email
Megan.Boland@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Kyunghee Burkitt
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Gillison
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Jimenez
Phone
210-593-5265
Email
isabel.jimenez@startsa.com
First Name & Middle Initial & Last Name & Degree
Amita Patnaik
Facility Name
South Texas Accelerated Research Therapeutics Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Herndon
Phone
801-907-4753
Email
mherndon@utahcancer.com
First Name & Middle Initial & Last Name & Degree
Justin Call
Facility Name
NEXT Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryanne Poole
Phone
703-280-5390
Email
mpoole@nextoncology.com
First Name & Middle Initial & Last Name & Degree
Alexander I Spira
Facility Name
Institut Jules Bordet
City
Anderlecht
State/Province
Other
ZIP/Postal Code
B-1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Kotecki
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Other
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Spreafico
Facility Name
McGill University Department of Oncology / McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramy Saleh
Facility Name
Institut Curie
City
Paris cedex 05
State/Province
Other
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Le Tourneau
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Other
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Champiat
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
State/Province
Other
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Ochsenreither
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
Other
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Curigliano
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
State/Province
Other
ZIP/Postal Code
37136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Zivi
Facility Name
Antoni Van Leeuwenhoekziekenhuis
City
Amsterdam
State/Province
Other
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeltje Steeghs
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Other
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Garralda Cabanas
Facility Name
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
City
Barcelona
State/Province
Other
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Oliva
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Other
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Fontana
Facility Name
The Royal Marsden Hospital
City
Surrey
State/Province
Other
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Minchom
12. IPD Sharing Statement
Learn more about this trial
A Study of SGN-PDL1V in Advanced Solid Tumors
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