A Study of SGN-PDL1V in Advanced Solid Tumors

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

Tracking Information

• First Submitted Date: December 15, 2021
• First Posted Date: January 26, 2022
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: October 25, 2022
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2022)

• 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.
• Number of participants with laboratory abnormalities [ Time Frame: Through approximately 90 days after last study treatment; up to 3 years ]
• Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]
• Number of participants with DLTs by dose level [ Time Frame: Through the first cycle of study treatment; approximately 1 month ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 31, 2024)

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

Original Secondary Outcome Measures (submitted: January 12, 2022)

• 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 subjects 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 [ Time Frame: Up to approximately 3 years ]
  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 [ 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.
• Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
  The time from the start of study treatment to death due to any cause.
• 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
• 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
• PK parameter - Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
  To be summarized using descriptive statistics
• PK parameter - Apparent terminal half (t1/2) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
  To be summarized using descriptive statistics
• 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
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of SGN-PDL1V in Advanced Solid Tumors
• Official Title: A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

Intervention

• 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

Study Arms

• Experimental: SGN-PDL1V Monotherapy
  SGN-PDL1V monotherapy
  Intervention: Drug: SGN-PDL1V
• Experimental: SGN-PDL1V Combination Therapy
  SGN-PDL1V + pembrolizumab
  Interventions:

  • Drug: SGN-PDL1V
  • Drug: pembrolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 31, 2024): 322
• Original Estimated Enrollment (submitted: January 12, 2022): 305
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Spain, Belgium, Canada, France, Germany, Italy, Netherlands, United Kingdom, United States

Administrative Information

• NCT Number: NCT05208762
• Other Study ID Numbers: SGNPDL1V-001; 2021-003517-19 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seagen Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Seagen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Andres Forero-Torres, MD; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: March 2024