Comparing PF-08046054 with pembrolizumab for non-small-cell lung carcinoma
Official title: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- Phase 1
- 2 groups
- Sites in Toronto and Montreal
- Recruiting
Interventions
- Medication
PF-08046054
Given into the vein (IV; intravenously)
- Medication
pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
University Health Network
Toronto, Ontario
- Recruiting
University Health Network, Princess Margaret Hospital
Toronto, Ontario
- Recruiting
McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
- +Participants must have PD-L1 expression based on historical testing
- +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
- +Participants must have PD-L1 expression based on historical testing
- +Parts A and B:
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, should have no appropriate SoCStandard of careThe treatment normally given for a condition outside a study.Read more → therapeutic option
- +Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
- +Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
- +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
- +Gastric cancer
- +Endometrial cancer
- +Part D and Part E:
- +Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
- +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →
Exclusion
- −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
- −History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
- −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 EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (NCI CTCAE) v5.0.
- −There are additional inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →. The study center will determine if criteria for participations are met.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives PF-08046054.
Registry label: A: PF-08046054 Monotherapy
Group B receives PF-08046054, together with one or more of: pembrolizumab.
Registry label: B: PF-08046054 Combination Therapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 714 people.
The study is currently expected to finish around January 2029.
The main measurement is taken over: Through approximately 90 days after last study treatment; up to 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Through approximately 90 days after last study treatment; up to 3 years.
Number of participants with laboratory abnormalities — measured over Through approximately 90 days after last study treatment; up to 3 years.
Number of participants with dose-limiting toxicities (DLTs) — measured over Through the first cycle of study treatment; approximately 1 month.
Number of participants with DLTs by dose level — measured over Through the first cycle of study treatment; approximately 1 month.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05208762 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PF-08046054Drug
Given into the vein (IV; intravenously)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About pembrolizumabDrug
200 mg once every 3 weeks given into the vein (IV; intravenously)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through approximately 90 days after last study treatment; up to 3 years.
The study as a whole is currently expected to finish around 2029-01-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 714 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States; Farmington Hills, Michigan, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.