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Advanced/Metastatic Solid TumorsPhase 1NCT07090499

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

A Phase 1 study testing PF-08046876, Pembrolizumab and Cisplatin in people with Advanced/Metastatic Solid Tumors and Bladder Cancer, run by Pfizer at 31 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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'. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08046876, Pembrolizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
31 sitesin 6 countries
Study dates
20 Aug 2025to 8 Jul 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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 join

  • 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 protocol exclusion
  • Pulmonary disease meeting protocol exclusion
  • Other unacceptable abnormalities as defined by protocol
  • Part 3: Meet contraindications of combination products per protocol and/or local labels

Trial locations and contacts

31 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

31 sites in 6 countries

United States21 sites, 21 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • The University of Texas MD Anderson Cancer Center - Conroe

    Conroe, Texas, 77384

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - West Houston

    Houston, Texas, 77079

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - League City

    League City, Texas, 77573

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Not yet recruiting

  • UCLA Department of Medicine-Hematology/Oncology

    Los Angeles, California, 90095

    Not yet recruiting

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Smilow Cancer Hospital - Yale New Haven Health

    New Haven, Connecticut, 06510

    Recruiting

  • Yale - New Haven Hospital - Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511

    Recruiting

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02467

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Recruiting

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

    Not yet recruiting

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

    Not yet recruiting

  • The University of Texas, MD Anderson Cancer Center - Sugar Land

    Sugar Land, Texas, 77478

    Recruiting

  • Smilow Cancer Hospital - Trumbull

    Trumbull, Connecticut, 06611

    Recruiting

Other trials in United States

Canada3 sites, 3 recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Spain3 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

Other trials in Spain

United Kingdom2 sites, 2 recruiting

  • Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London

    London, EC1A 7BE

    Not yet recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Not yet recruiting

Other trials in China

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

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. 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.

Being tested
PF-08046876, Pembrolizumab, Cisplatin, Carboplatin
Keywords
B6C, integrin beta 6, ADC, antibody drug conjugate, bladder cancer, urothelial carcinoma, non-small cell lung cancer, NSCLC, head and neck cancer, HNSCC, SCCHN, esophageal cancer, EC, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma, pancreatic cancer, PDAC, pancreatic adenocarcinoma, esophageal adenocarcinoma, lung adenocarcinoma
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08046876Drug

    Intravenous administration

  • PembrolizumabCombination product

    Intravenous administration

  • CisplatinCombination product

    Intravenous administration

  • CarboplatinCombination product

    Intravenous administration

Study groups in NCT07090499
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalDifferent groups of participants will receive different doses and/or schedules of the study drug
Receives: Drug: PF-08046876
Part 2 Dose ExpansionExperimentalParticipants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Receives: Drug: PF-08046876
Part 2 Dose OptimizationExperimentalParticipants will be enrolled to 2 dosing regimens deemed to be safe in Part 1
Receives: Drug: PF-08046876
Part 3 - Combination Cohort 1ExperimentalParticipants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Receives: Drug: PF-08046876; Combination Product: Pembrolizumab
Part 3 - Combination Cohort 2ExperimentalParticipants 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
Receives: Drug: PF-08046876; Combination Product: Pembrolizumab; Combination Product: Carboplatin
Part 3 - Combination Cohort 3ExperimentalParticipants 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
Receives: Drug: PF-08046876; Combination Product: Cisplatin
Part 3 - Combination Cohort 4ExperimentalParticipants 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
Receives: Drug: PF-08046876; Combination Product: Carboplatin
Part 3 - Combination Cohort 5ExperimentalParticipants with advanced urothelial cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Receives: Drug: PF-08046876; Combination Product: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation

    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.

    Measured: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

  2. Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy

    Occurrence of DLTs as defined by the protocol

    Measured: Baseline to end of DLT evaluation period

  3. Part 1: Recommended Monotherapy Dose for Expansion

    RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings

    Measured: Baseline to 30 days post last study drug administration

  4. Part 2: Recommended Monotherapy Phase 2 Dose

    RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.

    Measured: Baseline to 30 days post last study drug administration

  5. Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion

    RP2D/RDE will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.

    Measured: Baseline to 30 days post last study drug administration

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

    Measured: Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)

  2. Duration of Response (DOR)

    DOR as defined per RECIST 1.1.

    Measured: From the date of the first objective response to the date of disease progression or death (approximately 2 years)

  3. Progression Free Survival (PFS)

    PFS as defined per RECIST 1.1.

    Measured: From Baseline to date of first disease progression or death (approximately 2 Years)

  4. Overall Survival (OS)

    OS defined as the time until death due to any cause.

    Measured: From baseline to up to 3 years

  5. Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)

    Evaluate the single and multiple dose PK of PF-08048676.

    Measured: Baseline to approximately 30 days after last dose of study drug

  6. PK: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Evaluate the single and multiple dose PK of PF-08048676.

    Measured: Baseline to approximately 30 days after last dose of study drug

  7. PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

    Evaluate the single and multiple dose PK of PF-08048676.

    Measured: Baseline to approximately 30 days after last dose of study drug

  8. Incidence of Anti-Drug Antibody (ADA)

    To evaluate the immunogenicity of PF-08046876.

    Measured: Baseline to approximately 30 days after last dose of study drug

  9. Incidence of Neutralizing Antibodies (NAb)

    To evaluate the immunogenicity of PF-08046876.

    Measured: Baseline to approximately 30 days after last dose of study drug

  10. Percent change of immune cells within tumors based on multiplex immunofluorescence

    This measure will assess changes in the presence or activation of immune cells in the tumor microenvironment using RNA and/or Immunohistochemistry (IHC) assays.

    Measured: Baseline through 4-7 weeks after first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start20 Aug 2025
  3. Primary completion8 Jul 2028 (estimated)
  4. Study completion8 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07090499
Sponsor's protocol ID
C5951001
Other IDs
2025-521729-33-00, 2025
Status last verified
Oct 2026
First submitted
21 Jul 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08046876, Pembrolizumab and Cisplatin in people with Advanced/Metastatic Solid Tumors and Bladder Cancer, run by Pfizer at 31 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada, Spain, United Kingdom, China and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation (time frame: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07090499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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