Comparing 3 approaches for advanced/metastatic solid tumors
Official title: A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
- Phase 1
- 3 groups
- Sites in Toronto and Montreal
- Recruiting
Interventions
- Medication
PF-08046876
Intravenous administration
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 years of age or older
- +Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
- +Measurable disease
- +Part 1: progression or relapse following standard treatments
- +Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting
- +Resolution of acute effects of prior anticancer therapy to baselineBaselineYour starting measurements, taken before treatment begins.Read more → or Grade 1
- +ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to submit required pre-treatment tumor tissue as medically feasible
- +ECOG Performance status 0-1
Exclusion
- −Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
- −Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocolProtocolThe detailed plan a study must follow.Read more → exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more →
- −Pulmonary disease meeting protocol exclusion
- −Other unacceptable abnormalities as defined by protocol
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 3 groups in this study.
Groups A, B and C receive PF-08046876.
Registry label: A: Part 1 Dose Escalation · B: Part 2 Dose Optimization · C: Part 2 Dose Expansion
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
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 this field:
- 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 540 people.
The study is currently expected to finish around July 2029.
The main measurement is taken over: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of Treatment Emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs) estimated during the Adverse Events (AE) evaluation — measured over Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first).
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to end of DLT evaluation period.
Part 1: Recommended Monotherapy Dose for Expansion — measured over Baseline to 30 days post last study drug administration.
Part 2: Recommended Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → Dose — measured over Baseline to 30 days post last study drug administration.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07090499 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-08046876Drug
Intravenous administration
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.
There is only one group in this study, so there is no assignment to different treatments.
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: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first).
The study as a whole is currently expected to finish around 2029-07-08.
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 540 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.
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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.