We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of SGN-ALPV in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05229900
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Endometrial Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Uterine Cervical Neoplasms Testicular Neoplasms Drug: SGN-ALPV Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
Actual Study Start Date : April 21, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SGN-ALPV
SGN-ALPV monotherapy
 Drug: SGN-ALPV
Given into the vein (IV; intravenously)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days after last study treatment, approximately 6 months ]
    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.

  2. Number of participants with laboratory abnormalities [ Time Frame: Through 30-37 days after last study treatment, approximately 6 months ]
  3. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  4. Number of participants with DLTs by dose level [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Incidence of antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after last study treatment, approximately 6 months ]
  2. Area under the concentration-time curve (AUC) [ Time Frame: Through 14 days after last study treatment, approximately 6 months ]
    PK parameter

  3. Maximum concentration (Cmax) [ Time Frame: Through 14 days after last study treatment, approximately 6 months ]
    PK parameter

  4. Time to Cmax (Tmax) [ Time Frame: Through 14 days after last study treatment, approximately 6 months ]
    PK parameter

  5. Apparent terminal half-life (t1/2) [ Time Frame: Through 14 days after last study treatment, approximately 6 months ]
    PK parameter

  6. Trough concentration (Ctrough) [ Time Frame: Through 14 days after last study treatment, approximately 6 months ]
    PK parameter

  7. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Approximately 2 years ]
    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.

  8. Duration of objective response (DOR) [ Time Frame: Approximately 2 years ]
    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.

  9. Progression-free survival (PFS) [ Time Frame: Approximately 2 years ]
    The time from start of study treatment to first documentation of disease progression or death due to any cause

  10. Overall survival (OS) [ Time Frame: Approximately 2 years ]
    The time from start of study treatment to death due to any cause

  11. CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only) [ Time Frame: Approximately 2 years ]
    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

  12. Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only) [ Time Frame: Approximately 2 years ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05229900


Contacts
Layout table for location contacts
Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
Layout table for location information
United States, California
Women's Cancer Care Recruiting
Fresno, California, United States, 93710
Contact: Micheal Mott    559-650-4880    mmott@cogi-wcrn.com   
Principal Investigator: Christopher Perkins         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Yale Cancer Center Ct.Gov Contact       yale.ctgov@yale.edu   
Principal Investigator: Patricia LoRusso         
United States, Florida
Florida Cancer Specialists - Lake Nona Recruiting
Wellington, Florida, United States, 33414
Contact: Leslie Hertweck       Leslie.Hertweck@SarahCannon.com   
Principal Investigator: Cesar Perez Batista, MD         
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Julie Burns    616-954-5559    julie.burns@startmidwest.com   
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, Oklahoma
Oklahoma University at Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Julia Neuenschwander    405-271-8001 ext x48563    Julia-neuenschwander@ouhsc.edu   
Principal Investigator: Kathleen Moore         
United States, Utah
START Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Amanda Riojas    210-593-5238    amanda.riojas@startsa.com   
Principal Investigator: Justin Call         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Maryanne Poole    703-280-5390    mpoole@nextoncology.com   
Principal Investigator: Alexander I Spira         
Canada, Ontario
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Arif Awan         
Spain
START Madrid-CIOCC_Hospital HM Sanchinarro Recruiting
Madrid, Other, Spain, 28050
Principal Investigator: Maria Jose de Miguel         
United Kingdom
The Royal Marsden NHS Foundation Trust (RM) Recruiting
London, Other, United Kingdom, SW3 6JJ
Principal Investigator: Anna Minchom         
Sarah Cannon Research Institute UK Recruiting
London, Other, United Kingdom, W1G 6AD
Principal Investigator: Elisa Fontana         
Sponsors and Collaborators
Seagen Inc.
Investigators
Layout table for investigator information
Study Director: Suzanne McGoldrick, MD Seagen Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT05229900    
Other Study ID Numbers: SGNALPV-001
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Ovarian cancer
Endometrial cancer
Non-small cell lung cancer
NSCLC
Gastric cancer
Cervical cancer
 Malignant Testicular Germ Cell Tumor
Malignant Ovarian Germ Cell Tumor
High-grade serous ovarian cancer
HGSOC
Seattle Genetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Stomach Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Testicular Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases