PF-08046876 for Bladder Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Antibody drug conjugates

Disqualifiers: Pulmonary disease, Intestinal obstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effects of a new cancer treatment called PF-08046876, an investigational drug designed to target and kill cancer cells. The trial focuses on individuals with advanced cancers of the bladder, lung, head and neck, esophagus, or pancreas. Participants receive the drug through an IV (a needle in a vein) in varying doses and schedules to determine the best option. This trial suits those whose cancer has progressed after standard treatments or who have had a limited number of prior treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that PF-08046876 is likely to be safe for humans?

Research has shown that PF-08046876 is being tested for safety in people with advanced cancers, such as bladder cancer. This treatment is an experimental cancer drug known as an antibody-drug conjugate (ADC), designed to attach to and destroy cancer cells.

Since PF-08046876 is in the early testing stages, its safety is under close observation. In these initial trials, researchers administer different doses to find the right balance between safety and effectiveness. They aim to determine the safest amount of the drug to administer without causing harm.

Currently, the drug is being evaluated for safety, and any side effects are recorded. While specific side effects remain unknown, the trial seeks to identify doses that are safe and well-tolerated. This step is crucial to ensure the treatment's safety for more extensive future tests.

The focus remains on finding a safe dose, with detailed safety information collected as the study progresses. Trial participants help researchers gain insights into the drug's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PF-08046876 for bladder cancer because it offers a fresh approach by potentially targeting cancer cells more selectively. Unlike standard treatments like chemotherapy, which attack rapidly dividing cells indiscriminately, PF-08046876 is designed to hone in on specific cancer pathways, aiming for a more precise attack on tumor cells. This targeted mechanism could mean fewer side effects and improved effectiveness, offering new hope for patients who may not respond well to existing therapies.

What evidence suggests that PF-08046876 might be an effective treatment for advanced cancer?

Research shows that PF-08046876, an antibody-drug conjugate (ADC), is designed to locate and destroy cancer cells. Early results suggest it might help treat various cancers, including bladder cancer. ADCs attach to cancer cells and deliver a drug that kills them. Although limited data exists on PF-08046876 in human trials, it appears promising due to its direct targeting of cancer cells. Participants in this trial will receive PF-08046876 in different dosing regimens to assess its safety and effectiveness. Success with other ADCs in treating similar conditions supports the potential of this treatment. More studies are needed to confirm these early findings. ^{1 3 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced bladder, lung, head and neck, esophagus, or pancreatic cancer. Participants should have measurable disease and be in good physical condition (ECOG status 0-1). They must have tried standard treatments without success or had a maximum of two prior systemic therapies if they're in part two of the study.

Inclusion Criteria

I have had no more than 2 treatments for my advanced cancer.

I am 18 years old or older.

My cancer is in an advanced stage and is located in the bladder, lung, head and neck, esophagus, or pancreas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1 Dose Escalation

Different groups of participants will receive different doses and/or schedules of the study drug

Up to 30 days after last dose

Treatment - Part 2 Dose Expansion

Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1

Up to 30 days after last dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• PF-08046876

Trial Overview The trial is testing PF-08046876, an investigational antibody drug conjugate designed to target and kill cancer cells. It's given via intravenous infusion. The first part varies doses among groups; later parts may alter dosing schedules.

How Is the Trial Designed?

Group I: Part 2 Dose Optimization Experimental Treatment 1 Intervention

Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1

Group II: Part 2 Dose Expansion Experimental Treatment 1 Intervention

Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1

Group III: Part 1 Dose Escalation Experimental Treatment 1 Intervention

Different groups of participants will receive different doses and/or schedules of the study drug

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07090499

NCT07090499 | A Study to Learn About the ... 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, ...

2. withpower.com withpower.com/trial/phase-1-urinary-bladder-neoplasms-7-2025-21ca2

PF-08046876 for Bladder Cancer 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, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39721833

Real-world Effectiveness of Single-Agent Enfortumab Vedotin ... EV demonstrates efficacy in patients with mUC regardless of prior receipt of platinum-based chemotherapy and PD-1/L1 inhibitors or treatment line.

4. urotoday.com urotoday.com/component/acymailing/listid-131/mailid-13902-real-world-insights-on-bladder-cancer-treatment-trends.html

Real-World Insights on Bladder Cancer Treatment Trends Jacob Moyer presented real-world outcomes of nadofaragene firadenovec in BCG-unresponsive NMIBC at ASCO GU 2025, showing promising efficacy and safety data.

5. medium.com medium.com/@wuhanmabnus/tumor-immune-regulatory-target-itgb6-d8aab73ed80f

Tumor immune regulatory target ITGB6 | by Mabnus_bio These results suggest that PF-08046876 is a promising ADC for the treatment of multiple cancers and support further clinical development. A ...

6. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct07090499-advancedmetastatic-solid-tumors-trial

Clinical Trial for Advanced/Metastatic 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, ...

7. bcan.org bcan.org/clinicaltrials/a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors/

A Study to Learn About the Study Medicine Called PF ... 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, ...

8. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors

A Study to Learn About the Study Medicine Called PF ... 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 ...