A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- Conditions
- Carcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckMelanomaEsophageal Squamous Cell CarcinomaOvarian NeoplasmsTriple Negative Breast NeoplasmsGastric Cancer
- Interventions
- Registration Number
- NCT05208762
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 315
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PF-08046054 Monotherapy PF-08046054 PF-08046054 monotherapy PF-08046054 Combination Therapy PF-08046054 PF-08046054 + pembrolizumab PF-08046054 Combination Therapy pembrolizumab PF-08046054 + pembrolizumab
- Primary Outcome Measures
Name Time Method 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 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.
Number of participants with laboratory abnormalities Through approximately 90 days after last study treatment; up to 3 years
- Secondary Outcome Measures
Name Time Method Confirmed 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 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 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.
Overall survival (OS) 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) Through 30-37 days after last study treatment; up to approximately 3 years To be summarized using descriptive statistics
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.
PK parameter - Maximum concentration (Cmax) 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) Through 30-37 days after last study treatment; up to approximately 3 years To be summarized using descriptive statistics
PK parameter - Trough concentration (Ctrough) Through 30-37 days after last study treatment; up to approximately 3 years To be summarized using descriptive statistics
Trial Locations
- Locations (42)
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
🇩🇪Berlin, Germany
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
🇮🇹Bologna, Italy
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-cho, Shizuoka, Japan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS Pharmacy
🇺🇸Birmingham, Alabama, United States
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Karmanos Cancer Institute
🇺🇸Farmington Hills, Michigan, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
🇺🇸Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
🇺🇸San Antonio, Texas, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
Institut Jules Bordet
🇧🇪Anderlecht, Belgium
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Clinique Ambroise Pare
🇫🇷Neuilly sur seine, France
Institut Curie
🇫🇷Paris Cedex 05, France
lnstitut Curie Pharmacy
🇫🇷Paris, France
Gustave Roussy Institute - Service pharmacie
🇫🇷Villejuif, France
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
🇮🇹Milano, Milan, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
🇮🇹Verona, Other, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
🇮🇹Verona, Veneto, Italy
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
CETIR Viladomat
🇪🇸Barcelona, Other, Spain
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
🇪🇸Barcelona, Other, Spain
Hospital Quiron Salud Barcelona
🇪🇸Barcelona, Spain
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Diagnostic Centre
🇬🇧London, Others, United Kingdom
The Harley Street Clinic (THSC)
🇬🇧London, Other, United Kingdom
Pharmacy: Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
Radiology
🇬🇧London, United Kingdom