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Clinical Trials in the UK / NCT05208762
Recruiting Phase 1

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

NCT05208762 · tracked via the Priya Life Science UK tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 1
Started
2022-10-25
Last updated
2026-07-22

Condition(s) studied

Carcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckEsophageal Squamous Cell CarcinomaTriple Negative Breast NeoplasmsGastric CancerEndometrial CancerPancreatic AdenocarcinomaHepatocellular Carcinoma

Investigational drug(s) / intervention(s)

PF-08046054pembrolizumab

PF-08046054: Given into the vein (IV; intravenously)

pembrolizumab: 200 mg once every 3 weeks given into the vein (IV; intravenously)

Study 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

Sex
ALL
Min age
18 Years
Max age
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) (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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of Alabama at Birmingham, IDS Pharmacy Birmingham Alabama Recruiting
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of Alabama at Birmingham Birmingham Alabama Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center Orange California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
University of California, Davis Medical Center Sacramento California Recruiting
University of Iowa Iowa City Iowa Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Karmanos Cancer Institute Farmington Hills Michigan Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center Dallas Texas Recruiting
UT Southwestern Medical Center - Redbird Dallas Texas Recruiting
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital Dallas Texas Recruiting
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital Dallas Texas Recruiting
University Of Texas Southwestern Medical Center Dallas Texas Recruiting
UT Southwestern - Simmons Cancer Center - Fort Worth Fort Worth Texas Recruiting
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services Houston Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
UT Southwestern - Simmons Cancer Center - Richardson/Plano Richardson Texas Recruiting
NEXT Virginia, LLC San Antonio Texas Recruiting
South Texas Accelerated Research Therapeutics, LLC San Antonio Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Institut Jules Bordet Anderlecht Belgium Recruiting
University Health Network Toronto Ontario Recruiting
University Health Network, Princess Margaret Hospital Toronto Ontario Recruiting
McGill University Health Centre Montreal Quebec Recruiting
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting
Beijing Friendship hospital, Capital Medical University Beijing China Recruiting
Hôpital Saint André - CHU Bordeaux Bordeaux France Recruiting
Clinique Ambroise Pare Neuilly-sur-Seine France Recruiting
Institut Curie Paris France Recruiting
lnstitut Curie Pharmacy Paris France Recruiting
Gustave Roussy Institute - Service pharmacie Villejuif France Recruiting
Gustave Roussy Institute Villejuif France Recruiting
Charite Comprehensive Cancer Center Berlin Germany Recruiting

+ 22 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05208762 on ClinicalTrials.gov ↗ ← All trials in the UK