A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Recruiting · NCT05208762 · Interventional (participants receive a specific treatment) · Lead sponsor: Seagen, a wholly owned subsidiary of Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
PF-08046054pembrolizumab
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
- Pancreatic cancer
- Hepatocellular carcinoma
- TNBC
- Gastric cancer
- Endometrial 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.
Where it is running
60 locations listed across 8 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of Alabama at Birmingham, IDS Pharmacy - Birmingham, Alabama, United States
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine, California, United States
- UC Irvine Health - Chao Family Comprehensive Cancer Center - Orange, California, 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 - Iowa City, Iowa, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Karmanos Cancer Institute - Farmington Hills, Michigan, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- University of Texas Southwestern Medical Center - Simmons Cancer Center - Dallas, Texas, United States
- UT Southwestern Medical Center - Redbird - Dallas, Texas, United States
- Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital - Dallas, Texas, United States
- University Of Texas Southwestern Medical Center - Dallas, Texas, United States
- UT Southwestern - Simmons Cancer Center - Fort Worth - Fort Worth, Texas, 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
- UT Southwestern - Simmons Cancer Center - Richardson/Plano - Richardson, Texas, United States
- NEXT Virginia, LLC - San Antonio, 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
- The Netherlands Cancer Institute - Amsterdam, Netherlands
- Institut Jules Bordet - Anderlecht, Belgium
- Hospital Quiron Salud Barcelona - Barcelona, Spain
- NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Beijing Friendship hospital, Capital Medical University - Beijing, China
- Charite Comprehensive Cancer Center - Berlin, Germany
- Charite Universitatsmedizin Berlin - Berlin, Germany
- Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum - Berlin, Germany
- UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna - Bologna, Italy
- Hôpital Saint André - CHU Bordeaux - Bordeaux, France
- The Royal Marsden NHS Foundation Trust - London, United Kingdom
- Sarah Cannon Research Institute - London, United Kingdom
- Radiology - London, United Kingdom
- START Madrid - CIOCC - Hospital Universitario HM Sanchinarro - Madrid, Spain
- Clinique Ambroise Pare - Neuilly-sur-Seine, France
- Institut Curie - Paris, France
- lnstitut Curie Pharmacy - Paris, France
- Gustave Roussy Institute - Service pharmacie - Villejuif, France
- Gustave Roussy Institute - Villejuif, France
- Beijing Friendship Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- National Cancer Center Hospital East - Kashiwa, Chiba, Japan
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia - Milan, Milan, Italy
- University Health Network - Toronto, Ontario, Canada
- University Health Network, Princess Margaret Hospital - Toronto, Ontario, Canada
- CETIR Viladomat - Barcelona, Other, Spain
- Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet) - Barcelona, Other, Spain
- The Harley Street Clinic (THSC) - London, Other, United Kingdom
- Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi - Verona, Other, Italy
- Diagnostic Centre - London, Others, United Kingdom
- McGill University Health Centre - Montreal, Quebec, Canada
- Shanghai East Hospital - Shanghai, Shanghai Municipality, China
- Shizuoka Cancer Center - Nagaizumi-cho, Shizuoka, Japan
- Pharmacy: Royal Marsden Hospital - Sutton, Surrey, United Kingdom
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →