Clinical trial NCT05208762: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Official title: A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Keywords: Non-small cell lung cancer
NSCLC
Head and neck squamous cell carcinoma
HNSCC
Ovarian cancer
Triple Negative Breast Cancer
TNBC
Gastric cancer
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will test the safety of a drug called PF-08046054/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 five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.


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) (except nasopharyngeal cancer)
    * 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. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
    * 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 and Part E:

  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
  * Participants must have PD-L1 expression based on historical testing
  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
  * Participants with HNSCC; PD--L1 expression ≥1 by CPS
* 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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through approximately 90 days after last study treatment; up to 3 years
measure: Number of participants with laboratory abnormalities
timeFrame: Through approximately 90 days after last study treatment; up to 3 years
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Through the first cycle of study treatment; approximately 1 month
measure: Number of participants with DLTs by dose level
timeFrame: Through the first cycle of study treatment; approximately 1 month
Secondary outcomes:
measure: Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
timeFrame: Up to approximately 3 years
measure: Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
timeFrame: Up to approximately 3 years
measure: Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
timeFrame: Up to approximately 3 years
measure: Overall survival (OS)
timeFrame: Up to approximately 3 years
measure: Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
timeFrame: Through 30-37 days after last study treatment; up to approximately 3 years
measure: PK parameter - Maximum concentration (Cmax)
timeFrame: Through 30-37 days after last study treatment; up to approximately 3 years
measure: PK parameter - Trough concentration (Ctrough)
timeFrame: Through 30-37 days after last study treatment; up to approximately 3 years
measure: Incidence of anti-drug antibodies (ADAs)
timeFrame: Through 30-37 days after last study treatment; up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, IDS Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Neuilly sur seine
country: France
facility: Clinique Ambroise Pare
city: Paris Cedex 05
country: France
facility: Institut Curie
city: Paris
country: France
facility: lnstitut Curie Pharmacy
city: Villejuif
country: France
facility: Gustave Roussy Institute - Service pharmacie
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
city: Milano
country: Italy
facility: Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
state: Milan
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
state: Other
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
state: Veneto
city: Bologna
country: Italy
facility: UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Nagaizumi-cho
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Barcelona
country: Spain
facility: CETIR Viladomat
state: Other
city: Barcelona
country: Spain
facility: Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
state: Other
city: Barcelona
country: Spain
facility: Hospital Quiron Salud Barcelona
city: Barcelona
country: Spain
facility: NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
city: London
country: United Kingdom
facility: Diagnostic Centre
state: Others
city: London
country: United Kingdom
facility: The Harley Street Clinic (THSC)
state: Other
city: Sutton
country: United Kingdom
facility: Pharmacy: Royal Marsden Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: London
country: United Kingdom
facility: Radiology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: