Recruiting
Phase 1

PF-08046876

Sponsor:

Pfizer

Code:

NCT07090499

Conditions

Advanced/Metastatic Solid Tumors

Bladder Cancer

Urothelial Carcinoma

Advanced Non-Small Cell Lung Cancer

Carcinoma, Non Small Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08046876

Pembrolizumab

Cisplatin

Carboplatin

Study Details

Brief 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'. 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.

Conditions

Advanced/Metastatic Solid Tumors

Bladder Cancer

Urothelial Carcinoma

Advanced Non-Small Cell Lung Cancer

Carcinoma, Non Small Cell Lung

Study ID

NCT07090499

Start date

Aug 20, 2025

Status verified date

Oct, 2026

Completion date

Jul 8, 2029

Anticipated

Primary completion date

Jul 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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

Study Design

Enrollment

540 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation

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

experimental: Part 2 Dose Expansion

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

experimental: Part 2 Dose Optimization

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

experimental: Part 3 - Combination Cohort 1

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

experimental: Part 3 - Combination Cohort 2

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

experimental: Part 3 - Combination Cohort 3

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

experimental: Part 3 - Combination Cohort 4

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

experimental: Part 3 - Combination Cohort 5

Participants with advanced urothelial cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab

Interventions

PF-08046876

Intravenous administration

Pembrolizumab

Intravenous administration

Cisplatin

Intravenous administration

Carboplatin

Intravenous administration

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) ]
  • Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy [ Time Frame: Baseline to end of DLT evaluation period ]
  • Part 1: Recommended Monotherapy Dose for Expansion [ Time Frame: Baseline to 30 days post last study drug administration ]
  • Part 2: Recommended Monotherapy Phase 2 Dose [ Time Frame: Baseline to 30 days post last study drug administration ]
  • Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion [ Time Frame: Baseline to 30 days post last study drug administration ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Smilow Cancer Hospital - Yale New Haven Health

Recruiting

New Haven, Connecticut, United States, 06510

Yale - New Haven Hospital - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Smilow Cancer Hospital Phase 1 Unit

Recruiting

New Haven, Connecticut, United States, 06511

Smilow Cancer Hospital - Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute - Chestnut Hill

Recruiting

Newton, Massachusetts, United States, 02467

Sarah Cannon Research Institute - Pharmacy

Recruiting

Nashville, Tennessee, United States, 37203

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas MD Anderson Cancer Center - Conroe

Recruiting

Conroe, Texas, United States, 77384

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

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

Recruiting

Houston, Texas, United States, 77079

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

Recruiting

League City, Texas, United States, 77573

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

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

Recruiting

Sugar Land, Texas, United States, 77478

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Pfizer

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

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
  • lung squamous cell carcinoma
  • integrin alpha-v beta-6 receptor
  • ITGB6

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.