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

StatusRecruiting

PhasePhase 1

SponsorPfizer

Started2025-08-20

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoint added 4 → 5 primary endpoints

See other at-risk trials from Pfizer

Amendment history

2026-09-03

Study Status, Study Design, Contacts/Locations v7

Primary endpoint(s) modified4 to 5 entries

WasIncidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation, Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy, Part 1: Recommended Monotherapy Dose for Expansion, Part 2: Recommended Phase 2 Dose

NowIncidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation, Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy, Part 1: Recommended Monotherapy Dose for Expansion, Part 2: Recommended Monotherapy Phase 2 Dose, Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion

Trial arms changed: 3 → 8

Interventions modified

Enrollment increased: 310 → 540 participants

Study sites30→31

2026-07-21

Study Status, Contacts/Locations v6

Study sites28→30

2026-04-06

Study Status, Contacts/Locations v5

Study sitesdetails revised at 3 of 28 sites

2026-03-17

Study Status, Contacts/Locations v4

Study sites13→28

2025-12-08

Study Status, Contacts/Locations v3

Study sites2→13

Show 2 earlier versions

2025-10-08

Study Status v2

Re-verified, no change to tracked fields

2025-09-28

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Primary completion date2028-08-19→2028-07-08

Completion date2029-08-19→2029-07-08

Start dateestimated 2025-08-07→confirmed 2025-08-20

Study sites0→2

2025-07-21

Original filing

Pfizer

431 trials monitored

See 32 trials at risk

Lung Cancer

4,033 trials monitored

See 210 trials at risk

Non-Small Cell Lung Cancer (NSCLC)

2,914 trials monitored

See 156 trials at risk

Head & Neck Cancer

2,051 trials monitored

See 116 trials at risk

and 3 more diseases

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.

Trial Details

NCT Number	NCT07090499
Lead Sponsor	Pfizer
Conditions	Advanced/Metastatic Solid Tumors, Bladder Cancer, Urothelial Carcinoma, Advanced Non-Small Cell Lung Cancer, Carcinoma, Non Small Cell Lung, Carcinoma, Squamous Cell of Head and Neck, Head and Neck Cancer, Esophageal Cancer +5 more
Enrollment	540 participants
Start Date	2025-08-20
Primary Completion	2028-07-08 (estimated)
Study Completion	2029-07-08 (estimated)
Updated on ClinicalTrials.gov	2026-10-01