Tests PF-08046876, a new drug, in adults with advanced solid tumors
Tests a new antibody drug in adults with advanced bladder or lung cancer.
Key facts
- Who runs it
- Pfizer
- Where
- Montreal and Toronto, CanadaSee the 2 sitesAlso in 5 other countries, 28 sites
- Trial code
- Registry title
- A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 540 people, planned
- Started
- 20 Aug 2025
- Expected to end
- 8 Jul 2029
- Type of study
- Interventional, 8 groups
- Treatments tested
- PF-08046876
- Pembrolizumab
- Cisplatin
- Carboplatin
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas, who have measurable disease and are fairly active in daily life.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas, with measurable disease. Daily activity level (ECOG) 0-1. Part 3 needs advanced lung or bladder cancer.
- Earlier treatment
- Part 1: the cancer got worse or came back after standard treatments. Part 2: at most 2 earlier lines of drug treatment for advanced disease. Part 3: depends on the combination group. Side effects of earlier cancer treatment must be gone or mild (Grade 1).
- Biomarker or test result
- Participants must agree to give tumor tissue taken before treatment, if medically possible.
Main reasons for not taking part
- Earlier treatment with an antibody drug conjugate that has a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan)
- Active loss of appetite, nausea or vomiting, or signs of a blocked bowel, as defined by the protocol
- Lung disease as defined by the protocol
- Part 3: contraindications to the combination medicines
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 18 years of age or older
- Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
- Measurable disease
- ECOG Performance status 0-1
- Part 1: progression or relapse following standard treatments
- Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting
- Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group
- Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
- Consent to submit required pre-treatment tumor tissue as medically feasible
Who cannot take part
- Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
- Pulmonary disease meeting protocol exclusion
- Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion
- Other unacceptable abnormalities as defined by protocol
- Part 3: Meet contraindications of combination products per protocol and/or local labels
Where in Canada
Also in 5 other countries, 28 sites
- McGill University Health CentreMontreal, CanadaTaking people
- Princess Margaret Cancer CentreToronto, CanadaTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.
The 8 groups in the trial
- Part 1 Dose EscalationTreatment being tested
Different groups of participants will receive different doses and/or schedules of the study drug
Treatment: PF-08046876
- Part 2 Dose ExpansionTreatment being tested
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Treatment: PF-08046876
- Part 2 Dose OptimizationTreatment being tested
Participants will be enrolled to 2 dosing regimens deemed to be safe in Part 1
Treatment: PF-08046876
- Part 3 - Combination Cohort 1Treatment being tested
Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Treatment: PF-08046876 and Pembrolizumab
- Part 3 - Combination Cohort 2Treatment being tested
Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab and carboplatin
Treatment: PF-08046876, Pembrolizumab, and Carboplatin
- Part 3 - Combination Cohort 3Treatment being tested
Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with cisplatin
Treatment: PF-08046876 and Cisplatin
- Part 3 - Combination Cohort 4Treatment being tested
Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with carboplatin
Treatment: PF-08046876 and Carboplatin
- Part 3 - Combination Cohort 5Treatment being tested
Participants with advanced urothelial cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Treatment: PF-08046876 and Pembrolizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
- Plain-language title
- Tests PF-08046876, a new drug, in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2026