Phase 1 Study of PF-08046033 in Advanced Solid Tumors
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
2 other identifiers
interventional
250
2 countries
6
Brief Summary
This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer. The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma. The study has two parts: In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing. Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer. Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedStudy Start
First participant enrolled
April 8, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 14, 2029
April 23, 2026
April 1, 2026
2.3 years
March 30, 2026
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Type, incidence and severity of participants with adverse events (AEs)
Type, incidence, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 5.0), seriousness, and relatedness of adverse events (AEs).
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Type, incidence, and severity of participants with laboratory abnormalities
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Number of participants with dose modifications
Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Incidence of dose-limiting toxicities (DLTs)
To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Recommended dose and schedule of PF-08046033 for expansion (RDE)
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
Up to 1 year
Secondary Outcomes (11)
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator
Up to 3 years
Duration of response (DOR) using RECIST v1.1 as assessed by investigator
Up to 3 years
Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator
Up to 3 years
Overall survival (OS) using RECIST v1.1 as assessed by investigator
Up to 3 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year
- +6 more secondary outcomes
Study Arms (10)
Part 1: Cohort 1
EXPERIMENTALParticipants will receive PF-08046033 dose level 1 intravenously (IV).
Part 1: Cohort 2
EXPERIMENTALParticipants will receive PF-08046033 dose level 2 IV.
Part 1: Cohort 3
EXPERIMENTALParticipants will receive PF-08046033 dose level 3 IV.
Part 1: Cohort 4
EXPERIMENTALParticipants will receive PF-08046033 dose level 4 IV.
Part 1: Cohort 5
EXPERIMENTALParticipants will receive PF-08046033 dose level 5 IV.
Part 1: Cohort 6
EXPERIMENTALParticipants will receive PF-08046033 dose level 6 IV.
Part 1: Cohort 7
EXPERIMENTALParticipants will receive PF-08046033 dose level 7 IV.
Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)
EXPERIMENTALPF-08046033: Specified dose IV on specified days
Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)
EXPERIMENTALPF-08046033: Specified dose IV on specified days
Part 2: Cohort 3 (Cutaneous Melanoma)
EXPERIMENTALPF-08046033: Specified dose IV on specified days
Interventions
Powder for solution for infusion.
Eligibility Criteria
You may qualify if:
- Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.
- Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).
- Participants must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
You may not qualify if:
- Participants with known clinically active central nervous system (CNS) metastases.
- Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
- Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
- Untreated clinically significant thromboembolic disease.
- Previous exposure to GPNMB-targeted therapy.
- Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (6)
Presbyterian/St Lukes Medical Center
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, 00935, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 9, 2026
Study Start
April 8, 2026
Primary Completion (Estimated)
July 14, 2028
Study Completion (Estimated)
July 14, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.