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Trial record 1 of 1 for:    05208762 | Recruiting, Not yet recruiting Studies | Spain
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A Study of SGN-PDL1V in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05208762
Recruitment Status : Recruiting
First Posted : January 26, 2022
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:

This study will test the safety of a drug called SGN-PDL1V alone and with pembrolizumab 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 four 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. In Part D, participants will be given SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of the Head and Neck Esophageal Squamous Cell Carcinoma Ovarian Neoplasms Melanoma Triple Negative Breast Neoplasms Gastric Cancer Drug: SGN-PDL1V Drug: pembrolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SGN-PDL1V Monotherapy
SGN-PDL1V monotherapy
 Drug: SGN-PDL1V
Given into the vein (IV; intravenously)
Experimental: SGN-PDL1V Combination Therapy
SGN-PDL1V + pembrolizumab
 Drug: SGN-PDL1V
Given into the vein (IV; intravenously)

Drug: pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Other Name: Keytruda


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Through approximately 90 days after last study treatment; up to 3 years ]
    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 approximately 90 days after last study treatment; up to 3 years ]
  3. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]
  4. Number of participants with DLTs by dose level [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]

Secondary Outcome Measures :
  1. Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment [ Time Frame: Up to approximately 3 years ]
    The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.

  2. Duration of objective response (DOR) per RECIST v1.1 by investigator assessment [ Time Frame: Up to approximately 3 years ]
    The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.

  3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment [ Time Frame: Up to approximately 3 years ]
    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.

  4. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
    The time from the start of study treatment to death due to any cause.

  5. Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
    To be summarized using descriptive statistics

  6. PK parameter - Maximum concentration (Cmax) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
    To be summarized using descriptive statistics

  7. PK parameter - Trough concentration (Ctrough) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
    To be summarized using descriptive statistics

  8. Incidence of anti-drug antibodies (ADAs) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
    To be summarized using descriptive statistics


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 HNSCC

      • NSCLC

        • Participants must have histologically or cytologically-confirmed NSCLC
      • Esophageal SCC
      • Ovarian cancer
      • Melanoma
      • TNBC
      • Gastric cancer
    • Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing

  • Part D:

    • Participants must have histologically or cytologically-confirmed disease of the HNSCC
    • 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.

Contacts and Locations
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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): NCT05208762


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Andres Forero-Torres, MD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT05208762    
Other Study ID Numbers: SGNPDL1V-001
2021-003517-19 ( EudraCT Number )
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Non-small cell lung cancer
NSCLC
Head and neck squamous cell carcinoma
HNSCC
Ovarian cancer
 Triple Negative Breast Cancer
TNBC
Gastric cancer
Seattle Genetics
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Stomach Neoplasms
Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of Head and Neck
Ovarian Neoplasms
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Neoplasms, Squamous Cell
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Breast Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases