A Study of SGN-PDL1V in Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma, Ovarian Neoplasms, Melanoma, Triple Negative Breast Neoplasms

Intervention / Treatment
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* Drug: SGN-PDL1V


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-PDL1V<br>SGN-PDL1V monotherapy | Drug: SGN-PDL1V<br>* Given into the vein (IV; intravenously)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 3 years | 
| 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. | Up to approximately 3 years | 
| 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. | Up to approximately 3 years | 
| Overall survival (OS) | The time from the start of study treatment to death due to any cause. | Up to approximately 3 years | 
| Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) | To be summarized using descriptive statistics | Through 30-37 days after last study treatment; up to approximately 3 years | 
| PK parameter - Maximum concentration (Cmax) | To be summarized using descriptive statistics | Through 30-37 days after last study treatment; up to approximately 3 years | 
| PK parameter - Trough concentration (Ctrough) | To be summarized using descriptive statistics | Through 30-37 days after last study treatment; up to approximately 3 years | 
| Incidence of anti-drug antibodies (ADAs) | To be summarized using descriptive statistics | Through 30-37 days after last study treatment; up to approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, NSCLC, Head and neck squamous cell carcinoma, HNSCC, Ovarian cancer, Triple Negative Breast Cancer, TNBC, Seattle Genetics