A Study of SGN-PDL1V in Advanced Solid Tumors

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208762
• Other study ID #: SGNPDL1V-001
• Secondary ID: 2021-003517-19
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-PDL1V
Given into the vein (IV; intravenously)
• pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Anderlecht	Other
Canada	McGill University Department of Oncology / McGill University Health Centre	Montreal	Quebec
Canada	University Health Network, Princess Margaret Hospital	Toronto	Other
France	Institut Curie	Paris cedex 05	Other
France	Institut Gustave Roussy	Villejuif	Other
Germany	Charite Universitatsmedizin Berlin	Berlin	Other
Italy	Istituto Europeo di Oncologia	Milano	Other
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona	Other
Netherlands	Antoni Van Leeuwenhoekziekenhuis	Amsterdam	Other
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Other
Spain	Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)	Barcelona	Other
Spain	START Madrid-CIOCC_Hospital HM Sanchinarro	Madrid	Other
United Kingdom	Sarah Cannon Research Institute UK	London	Other
United Kingdom	The Royal Marsden Hospital	Surrey	Other
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	NEXT Oncology	Fairfax	Virginia
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California Davis	Sacramento	California
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with laboratory abnormalities		Through approximately 90 days after last study treatment; up to 3 years
Primary	Number of participants with dose-limiting toxicities (DLTs)		Through the first cycle of study treatment; approximately 1 month
Primary	Number of participants with DLTs by dose level		Through the first cycle of study treatment; approximately 1 month
Secondary	Confirmed 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) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.	Up to approximately 3 years
Secondary	Duration of objective response (DOR) per RECIST v1.1 by investigator assessment	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.	Up to approximately 3 years
Secondary	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
Secondary	Overall survival (OS)	The time from the start of study treatment to death due to any cause.	Up to approximately 3 years
Secondary	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
Secondary	PK parameter - Maximum concentration (Cmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment; up to approximately 3 years
Secondary	PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment; up to approximately 3 years
Secondary	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