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2025-08-07
2028-08-19
2029-08-19
310
NCT07090499
Pfizer
Pfizer
INTERVENTIONAL
A Study to Learn About the Study Medicine Called PF-08046876 in People 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-07-21 | N/A | 2025-07-21 |
2025-07-21 | N/A | 2025-07-29 |
2025-07-29 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1 Dose Escalation Different groups of participants will receive different doses and/or schedules of the study drug | DRUG: PF-08046876
|
| EXPERIMENTAL: Part 2 Dose Optimization Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1 | DRUG: PF-08046876
|
| EXPERIMENTAL: Part 2 Dose Expansion Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1 | DRUG: PF-08046876
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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 | Occurrence of DLTs as defined by the protocol | Baseline to end of DLT evaluation period |
| Part 1: Recommended Monotherapy Dose for Expansion | RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings | Baseline to 30 days post last study drug administration |
| Part 2: Recommended Phase 2 Dose | RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings. | Baseline to 30 days post last study drug administration |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Duration of Response (DOR) | DOR as defined per RECIST 1.1. | From the date of the first objective response to the date of disease progression or death (approximately 2 years) |
| Progression Free Survival (PFS) | PFS as defined per RECIST 1.1. | From Baseline to date of first disease progression or death (approximately 2 Years) |
| Overall Survival (OS) | OS defined as the time until death due to any cause. | From baseline to up to 3 years |
| Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax) | Evaluate the single and multiple dose PK of PF-08048676. | Baseline to approximately 30 days after last dose of study drug |
| PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) | Evaluate the single and multiple dose PK of PF-08048676. | Baseline to approximately 30 days after last dose of study drug |
| PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) | Evaluate the single and multiple dose PK of PF-08048676. | Baseline to approximately 30 days after last dose of study drug |
| Incidence of Anti-Drug Antibody (ADA) | To evaluate the immunogenicity of PF-08046876. | Baseline to approximately 30 days after last dose of study drug |
| Incidence of Neutralizing Antibodies (NAb) | To evaluate the immunogenicity of PF-08046876. | Baseline to approximately 30 days after last dose of study drug |
| 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. | Baseline through 4-7 weeks after first dose of study drug |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Pfizer CT.gov Call Center Phone Number: 1-800-718-1021 Email: ClinicalTrials.gov_Inquiries@pfizer.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
