Non-Small-Cell LungPhase 1NCT07519655
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
A Phase 1 study testing PF-08046033 in people with Non-Small-Cell Lung and Esophageal Cancer, run by Pfizer at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
- What is being tested?
- PF-08046033
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 8 Apr 2026to 14 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
United States11 sites, 11 recruiting
- Recruiting
Presbyterian/St Lukes Medical Center
Denver, Colorado, 80218
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
- Recruiting
Inova Schar Cancer Infusion Pharmacy
Fairfax, Virginia, 22031
- Recruiting
Inova Schar Cancer
Fairfax, Virginia, 22031
- Recruiting
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
- Recruiting
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
- Recruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, 06511
- Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
- Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
France2 sites, 2 recruiting
- Recruiting
Oncopole Claudius Regaud
Toulouse, 31059
- Recruiting
Gustave Roussy
Villejuif, 94800
Puerto Rico2 sites, 2 recruiting
- Recruiting
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, 00935
- Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
About this study
Official title: A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
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.
Read more
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.
- Conditions
- Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
- Being tested
- PF-08046033
- Keywords
- Lung cancer, Esophageal cancer, Melanoma, Antibody drug conjugate
- Medical subject headings
- Esophageal Neoplasms, Melanoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08046033Drug
Powder for solution for infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Participants will receive PF-08046033 dose level 1 intravenously (IV). Receives: Drug: PF-08046033 |
| Part 1: Cohort 2 | Experimental | Participants will receive PF-08046033 dose level 2 IV. Receives: Drug: PF-08046033 |
| Part 1: Cohort 3 | Experimental | Participants will receive PF-08046033 dose level 3 IV. Receives: Drug: PF-08046033 |
| Part 1: Cohort 4 | Experimental | Participants will receive PF-08046033 dose level 4 IV. Receives: Drug: PF-08046033 |
| Part 1: Cohort 5 | Experimental | Participants will receive PF-08046033 dose level 5 IV. Receives: Drug: PF-08046033 |
| Part 1: Cohort 6 | Experimental | Participants will receive PF-08046033 dose level 6 IV. Receives: Drug: PF-08046033 |
| Part 1: Cohort 7 | Experimental | Participants will receive PF-08046033 dose level 7 IV. Receives: Drug: PF-08046033 |
| Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC) | Experimental | PF-08046033: Specified dose IV on specified days Receives: Drug: PF-08046033 |
| Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC) | Experimental | PF-08046033: Specified dose IV on specified days Receives: Drug: PF-08046033 |
| Part 2: Cohort 3 (Cutaneous Melanoma) | Experimental | PF-08046033: Specified dose IV on specified days Receives: Drug: PF-08046033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Objective response defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, from the date of first dose until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurs first.
Measured: Up to 3 years
Duration of response (DOR) using RECIST v1.1 as assessed by investigator
DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.
Measured: Up to 3 years
Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Up to 3 years
Overall survival (OS) using RECIST v1.1 as assessed by investigator
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to 3 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033
To characterize the PK of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year
PK: Area under the concentration-time curve (AUC) of PF-08046033
To characterize the PK of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Time to Maximum concentration (Tmax) of PF-08046033
To characterize the PK of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Trough concentration (Ctrough) of PF-08046033
To characterize the PK of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Terminal Elimination half-life (t1/2) of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Incidence of antidrug antibodies (ADAs)
To characterize the immunogenicity of PF-08046033
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Percent change of immune cells and PD-L1 expression based on immunohistochemistry
To evaluate the pharmacodynamic effects of PF-08046033 in tumor tissue
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start8 Apr 2026
- Primary completion14 Jul 2028 (estimated)
- Study completion14 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519655
- Sponsor's protocol ID
- C5921001
- Other IDs
- GPS [GPNMB-AurS]
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07519655
- Acronym / sponsor ID
- C5921001
- Conditions
- Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
- Keywords
- Lung cancer, Esophageal cancer, Melanoma, Antibody drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 14 Jul 2028 (estimated)
- Study completion
- 14 Jul 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 1 intravenously (IV). |
| Part 1: Cohort 2 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 2 IV. |
| Part 1: Cohort 3 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 3 IV. |
| Part 1: Cohort 4 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 4 IV. |
| Part 1: Cohort 5 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 5 IV. |
| Part 1: Cohort 6 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 6 IV. |
| Part 1: Cohort 7 | Experimental | Drug: PF-08046033Participants will receive PF-08046033 dose level 7 IV. |
| Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC) | Experimental | Drug: PF-08046033PF-08046033: Specified dose IV on specified days |
| Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC) | Experimental | Drug: PF-08046033PF-08046033: Specified dose IV on specified days |
| Part 2: Cohort 3 (Cutaneous Melanoma) | Experimental | Drug: PF-08046033PF-08046033: Specified dose IV on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-08046033Powder for solution for infusion. | Drug | Part 1: Cohort 1, Part 1: Cohort 2, Part 1: Cohort 3, Part 1: Cohort 4, Part 1: Cohort 5, Part 1: Cohort 6, Part 1: Cohort 7, Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC), Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC), Part 2: Cohort 3 (Cutaneous Melanoma) |
Primary outcome
Type, incidence and severity of participants with adverse events (AEs)
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year
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).
Type, incidence, and severity of participants with laboratory abnormalities
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
Number of participants with dose modifications
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year
Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs
Incidence of dose-limiting toxicities (DLTs)
Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year
To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033
Recommended dose and schedule of PF-08046033 for expansion (RDE)
Time frame: Up to 1 year
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
11 secondary outcomes
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator
Time frame: Up to 3 years
Duration of response (DOR) using RECIST v1.1 as assessed by investigator
Time frame: Up to 3 years
Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator
Time frame: Up to 3 years
Overall survival (OS) using RECIST v1.1 as assessed by investigator
Time frame: Up to 3 years
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year
PK: Area under the concentration-time curve (AUC) of PF-08046033
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Time to Maximum concentration (Tmax) of PF-08046033
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Trough concentration (Ctrough) of PF-08046033
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
PK: Terminal Elimination half-life (t1/2) of PF-08046033
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Incidence of antidrug antibodies (ADAs)
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Percent change of immune cells and PD-L1 expression based on immunohistochemistry
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-08046033 in people with Non-Small-Cell Lung and Esophageal Cancer, run by Pfizer at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, South Korea, France, Puerto Rico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence and severity of participants with adverse events (AEs) (time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.