PF-08046033 in adults with advanced lung, esophageal cancer or melanoma
Tests the new medicine PF-08046033 for safety in adults with advanced cancers.
Key facts
- Who runs it
- Pfizer
- Where
- Barcelona and Madrid, SpainSee the 2 sitesAlso in 5 other countries, 19 sites
- Trial code
- Registry title
- Phase 1 Study of PF-08046033 in Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 250 people, planned
- Started
- 8 Apr 2026
- Expected to end
- 14 Jul 2029
- Type of study
- Interventional, 10 groups
- Treatments tested
- PF-08046033
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (non-small cell), esophageal squamous cell cancer or skin melanoma that cannot be removed by surgery or has spread. It tests a new medicine, PF-08046033.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Metastatic or unresectable locally advanced non-small cell lung cancer, esophageal squamous cell cancer or cutaneous melanoma, confirmed by tissue examination. The cancer must be measurable. ECOG performance status must be 0-1.
- Earlier treatment
- The cancer must have progressed on, or the person cannot tolerate, standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2). Anyone with previous GPNMB-targeted therapy cannot join.
Main reasons for not taking part
- Known active metastases in the central nervous system (CNS)
- Existing neuropathy of Grade 2 or worse
- Uncontrolled diabetes with hemoglobin A1C of 10.0% (86 mmol/mol) or higher
- Untreated clinically significant thromboembolic disease
- Known or suspected allergy to any component of the study medicine
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous exposure to GPNMB-targeted therapy
- Untreated clinically significant thromboembolic disease
- Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention
- Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%
- Participants with known clinically active central nervous system (CNS) metastases
- Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0
Where in Spain
Also in 5 other countries, 19 sites
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 10 groups in the trial
- Part 1: Cohort 1Treatment being tested
Participants will receive PF-08046033 dose level 1 intravenously (IV).
Treatment: PF-08046033
- Part 1: Cohort 2Treatment being tested
Participants will receive PF-08046033 dose level 2 IV.
Treatment: PF-08046033
- Part 1: Cohort 3Treatment being tested
Participants will receive PF-08046033 dose level 3 IV.
Treatment: PF-08046033
- Part 1: Cohort 4Treatment being tested
Participants will receive PF-08046033 dose level 4 IV.
Treatment: PF-08046033
- Part 1: Cohort 5Treatment being tested
Participants will receive PF-08046033 dose level 5 IV.
Treatment: PF-08046033
- Part 1: Cohort 6Treatment being tested
Participants will receive PF-08046033 dose level 6 IV.
Treatment: PF-08046033
- Part 1: Cohort 7Treatment being tested
Participants will receive PF-08046033 dose level 7 IV.
Treatment: PF-08046033
- Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)Treatment being tested
PF-08046033: Specified dose IV on specified days
Treatment: PF-08046033
- Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)Treatment being tested
PF-08046033: Specified dose IV on specified days
Treatment: PF-08046033
- Part 2: Cohort 3 (Cutaneous Melanoma)Treatment being tested
PF-08046033: Specified dose IV on specified days
Treatment: PF-08046033
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
- Plain-language title
- PF-08046033 in adults with advanced lung, esophageal cancer or melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2026