A Study of SGN-ALPV in Advanced Solid Tumors
Primary Purpose
Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGN-ALPV
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovarian cancer, Endometrial cancer, Non-small cell lung cancer, NSCLC, Gastric cancer, GEJ carcinoma, Cervical cancer, Malignant Testicular Germ Cell Tumor, Malignant Ovarian Germ Cell Tumor, Malignant Extragonadal Germ Cell Tumor, High-grade serous ovarian cancer, HGSOC, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:
Parts A and B
- Ovarian cancer
- Endometrial cancer
- Non-small cell lung cancer (NSCLC)
- Gastric cancer
- Cervical cancer
- Malignant testicular germ cell tumor (GCT), except for pure teratomas
- Malignant ovarian GCT, except for pure teratomas
Part C
- High-grade serous ovarian cancer (HGSOC): Participants must have HGSOC which has progressed or relapsed within 6 months after previous platinum containing chemotherapy, received 2 to 4 prior anticancer lines of therapy, and at least 1 line of therapy in the platinum-resistant setting. If eligible at least 1 line of therapy must have contained bevacizumab or a biosimilar to bevacizumab.
- Endometrial Cancer: Participants must have unresectable locally advance or metastatic endometrial carcinoma and have had at least 1 prior line of therapy.
- NSCLC: Participants must have unresectable locally advanced or metastatic NSCLC and have received platinum-based therapy and a PD-(L)1 inhibitor.
- Gastric cancer: Participants must have unresectable locally advanced or metastatic gastric cancer and have received prior platinum and fluoropyrimidine -based chemotherapy
Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy
- Disease-specific expansion cohorts, subjects 16 onwards: pretreatment biopsy.
- Biology expansion cohort: pretreatment biopsy, on-treatment biopsy during Cycle 1, and end of treatment biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per the 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. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known active central nervous system metastases.
- Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Sites / Locations
- Women's Cancer Care
- Yale Cancer Center
- Florida Cancer Specialists - Lake Nona
- START Midwest
- Oklahoma University at Stephenson Cancer Center
- START Mountain Region
- Virginia Cancer Specialists
- Ottawa Hospital Cancer Centre
- University Health Network, Princess Margaret Hospital
- START Madrid-CIOCC_Hospital HM Sanchinarro
- Karolinska University Hospital
- The Royal Marsden NHS Foundation Trust (RM)
- Sarah Cannon Research Institute UK
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-ALPV
Arm Description
SGN-ALPV 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
Incidence of antidrug antibodies (ADAs)
Area under the concentration-time curve (AUC)
PK parameter
Maximum concentration (Cmax)
PK parameter
Time to Cmax (Tmax)
PK parameter
Apparent terminal half-life (t1/2)
PK parameter
Trough concentration (Ctrough)
PK parameter
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.
Duration of objective response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.
Progression-free survival (PFS)
The time from start of study treatment to first documentation of disease progression or death due to any cause
Overall survival (OS)
The time from start of study treatment to death due to any cause
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05229900
Brief Title
A Study of SGN-ALPV in Advanced Solid Tumors
Official Title
A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
November 30, 2027 (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-ALPV 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-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV 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
Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Gastroesophageal Junction Carcinoma, Uterine Cervical Neoplasms, Testicular Neoplasms
Keywords
Ovarian cancer, Endometrial cancer, Non-small cell lung cancer, NSCLC, Gastric cancer, GEJ carcinoma, Cervical cancer, Malignant Testicular Germ Cell Tumor, Malignant Ovarian Germ Cell Tumor, Malignant Extragonadal Germ Cell Tumor, High-grade serous ovarian cancer, HGSOC, 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
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGN-ALPV
Arm Type
Experimental
Arm Description
SGN-ALPV monotherapy
Intervention Type
Drug
Intervention Name(s)
SGN-ALPV
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 30-37 days after last study treatment, approximately 6 months
Title
Number of participants with laboratory abnormalities
Time Frame
Through 30-37 days after last study treatment, approximately 6 months
Title
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
Up to 28 days
Title
Number of participants with DLTs by dose level
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Incidence of antidrug antibodies (ADAs)
Time Frame
Through 30-37 days after last study treatment, approximately 6 months
Title
Area under the concentration-time curve (AUC)
Description
PK parameter
Time Frame
Through 14 days after last study treatment, approximately 6 months
Title
Maximum concentration (Cmax)
Description
PK parameter
Time Frame
Through 14 days after last study treatment, approximately 6 months
Title
Time to Cmax (Tmax)
Description
PK parameter
Time Frame
Through 14 days after last study treatment, approximately 6 months
Title
Apparent terminal half-life (t1/2)
Description
PK parameter
Time Frame
Through 14 days after last study treatment, approximately 6 months
Title
Trough concentration (Ctrough)
Description
PK parameter
Time Frame
Through 14 days after last study treatment, approximately 6 months
Title
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Description
The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.
Time Frame
Approximately 2 years
Title
Duration of objective response (DOR)
Description
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.
Time Frame
Approximately 2 years
Title
Progression-free survival (PFS)
Description
The time from start of study treatment to first documentation of disease progression or death due to any cause
Time Frame
Approximately 2 years
Title
Overall survival (OS)
Description
The time from start of study treatment to death due to any cause
Time Frame
Approximately 2 years
Title
CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)
Description
The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria
Time Frame
Approximately 2 years
Title
Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)
Description
The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:
Parts A and B
Ovarian cancer
Endometrial cancer
Non-small cell lung cancer (NSCLC)
Gastric cancer, including gastroesophageal junction (GEJ) carcinoma
Cervical cancer
Malignant testicular germ cell tumor (GCT), except for pure teratomas
Malignant ovarian GCT, except for pure teratomas
Malignant extragonadal GCT except for pure teratomas or tumors with primaries arising from CNS
Part C
High-grade serous ovarian cancer (HGSOC): Participants must have HGSOC which has progressed or relapsed within 6 months after previous platinum containing chemotherapy, received 2 to 4 prior anticancer lines of therapy, and at least 1 line of therapy in the platinum-resistant setting. If eligible at least 1 line of therapy must have contained bevacizumab or a biosimilar to bevacizumab.
Endometrial Cancer: Participants must have unresectable locally advance or metastatic endometrial carcinoma and have had at least 1 prior line of therapy.
NSCLC: Participants must have unresectable locally advanced or metastatic NSCLC and have received platinum-based therapy and a PD-(L)1 inhibitor.
Gastric cancer or GEJ carcinoma: Participants must have unresectable locally advanced or metastatic gastric cancer or GEJ carcinoma and have received prior platinum and fluoropyrimidine -based chemotherapy
Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy
Part B dose and schedule optimization cohorts and Part C disease-specific expansion cohorts: pretreatment biopsy, unless clinically infeasible following consultation with the medical monitor.
Part C biology expansion cohort: pretreatment biopsy (required), on-treatment biopsy during Cycle 1 (unless clinically infeasible following consultation with the medical monitor)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Measurable disease per the 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. Exceptions are malignancies with a negligible risk of metastasis or death.
Known active central nervous system metastases.
Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL2.
Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne McGoldrick, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Women's Cancer Care
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Florida Cancer Specialists - Lake Nona
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Oklahoma University at Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
START Madrid-CIOCC_Hospital HM Sanchinarro
City
Madrid
State/Province
Other
ZIP/Postal Code
28050
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
State/Province
Other
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
The Royal Marsden NHS Foundation Trust (RM)
City
London
State/Province
Other
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Other
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
12. IPD Sharing Statement
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A Study of SGN-ALPV in Advanced Solid Tumors
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