A Study of SGN-PDL1V in Advanced Solid Tumors

• Sponsor: Seagen Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05208762
• Collaborator: (none)
• Enrollment: 305
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 49
• Patients Per Site: 101.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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.

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	Drug: SGN-PDL1V	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 305 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
• Anticipated Study Start Date: Nov 30, 2022
• Anticipated Primary Completion Date: Jul 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-PDL1V SGN-PDL1V monotherapy	Drug: SGN-PDL1V; Given into the vein (IV; intravenously)

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs) [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 [Through approximately 90 days after last study treatment; up to 3 years]

3. Number of participants with dose-limiting toxicities (DLTs) [Through the first cycle of study treatment; approximately 1 month]

4. Number of participants with DLTs by dose level [Through the first cycle of study treatment; approximately 1 month]

Secondary Outcome Measures

1. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment [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.

2. Duration of objective response per RECIST v1.1 by investigator assessment [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.

3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment [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) [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) [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) [Through 30-37 days after last study treatment; up to approximately 3 years]

   To be summarized using descriptive statistics

7. PK parameter - Time to maximum concentration (Tmax) [Through 30-37 days after last study treatment; up to approximately 3 years]

   To be summarized using descriptive statistics

8. PK parameter - Apparent terminal half (t1/2) [Through 30-37 days after last study treatment; up to approximately 3 years]

   To be summarized using descriptive statistics

9. PK parameter - Trough concentration (Ctrough) [Through 30-37 days after last study treatment; up to approximately 3 years]

   To be summarized using descriptive statistics

10. Incidence of anti-drug antibodies (ADAs) [Through 30-37 days after last study treatment; up to approximately 3 years]

    To be summarized using descriptive statistics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

• 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

• 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

• 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 the last 6 months.

• 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

Locations

	Site	City	State	Country	Postal Code
1	South Texas Accelerated Research Therapeutics	San Antonio	Texas	United States	78229
2	South Texas Accelerated Research Therapeutics Mountain Region	West Valley City	Utah	United States	84119
3	University Health Network, Princess Margaret Hospital	Toronto		Canada	M5G 2C1

Sponsors and Collaborators

• Seagen Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seagen Inc.
• ClinicalTrials.gov Identifier: NCT05208762
• Other Study ID Numbers: SGNPDL1V-001; 2021-003517-19
• First Posted: Jan 26, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• 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; Seattle Genetics
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Ovarian Neoplasms

Study Results

No Results Posted as of Aug 25, 2022