Malignant MelanomaPhase 1NCT06799533
A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors
A Phase 1 study testing PF-08046031 in people with Malignant Melanoma and Melanoma, run by Pfizer at 11 sites in 5 countries.
Trial summary
This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Melanoma, Metastatic Melanoma
- What is being tested?
- PF-08046031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 1 May 2025to 23 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
- Participants who have refused available standard of care therapies are not eligible.
Who cannot join
- Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease.
- Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy. Previous history of non-infectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening.
- Other protocol specific criteria might apply.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States7 sites
Presbyterian/ St. Lukes Medical Center
Denver, Colorado, 80218
Sarah Cannon Research Institute at HealthONE - SCRI - PPDS
Denver, Colorado, 80218
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404
Spain1 site
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
Sweden1 site
Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01], 171 64
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.
- Conditions
- Malignant Melanoma, Melanoma, Metastatic Melanoma, Solid Tumors
- Being tested
- PF-08046031
- Keywords
- Solid tumors, Other Solid tumors
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08046031Drug
Given into the vein (IV; intravenous)
| Study group | Role | What they receive |
|---|---|---|
| PF-08046031 monotherapy | Experimental | PF-08046031 Receives: Drug: PF-08046031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: through 30 days after the last study treatment; approximately 6 months
Number of participants with laboratory abnormalities
Measured: through 30days after the last study treatment; approximately 6 months
Number of participants with dose limiting toxicities
Measured: up to 28 days
Secondary outcomes (10)
number of participants with antidrug antibodies
To be summarized using descriptive statistics
Measured: through 30 days after the last study treatment; approximately 6 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics
Measured: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Maximum Concentration (Cmax)
To be summarized using descriptive statistics
Measured: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics
Measured: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
Measured: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Measured: Through 30 days after the last study treatment; approximately 6 months
Objective response rate (ORR)
The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigato
Measured: Up to approximately 1 year
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause
Measured: Up to approximately 1 year
Progression-free survival (PFS)
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause
Measured: Up to approximately 1 year
Overall survival (OS)
The time from the start of study treatment to death due to any cause
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 May 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Why it stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT06799533
- Sponsor's protocol ID
- C5901001
- Other IDs
- 2024-514745-10-00
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2025
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
- ClinicalTrials.gov ID
- NCT06799533
- Acronym / sponsor ID
- C5901001
- Conditions
- Malignant Melanoma, Melanoma, Metastatic Melanoma, Solid Tumors
- Keywords
- Solid tumors, Other Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 29 Jan 2025 (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 study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| PF-08046031 monotherapy | Experimental | Drug: PF-08046031PF-08046031 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
- Participants who have refused available standard of care therapies are not eligible.
Key exclusion criteria (4 listed)
- Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease.
- Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy. Previous history of non-infectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening.
- Other protocol specific criteria might apply.
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-08046031Given into the vein (IV; intravenous) | Drug | PF-08046031 monotherapy |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: through 30 days after the last study treatment; approximately 6 months
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
Time frame: through 30days after the last study treatment; approximately 6 months
Number of participants with dose limiting toxicities
Time frame: up to 28 days
10 secondary outcomes
number of participants with antidrug antibodies
Time frame: through 30 days after the last study treatment; approximately 6 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Maximum Concentration (Cmax)
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Time to maximum concentration (Tmax)
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Apparent terminal half-life (t1/2)
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Trough concentration (Ctrough)
Time frame: Through 30 days after the last study treatment; approximately 6 months
Objective response rate (ORR)
Time frame: Up to approximately 1 year
Duration of response (DOR)
Time frame: Up to approximately 1 year
Progression-free survival (PFS)
Time frame: Up to approximately 1 year
Overall survival (OS)
Time frame: Approximately 2 years
Results and safety
The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Related trials for Malignant Melanoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruiting
Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D System.
Naevi
Not yet recruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
11 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-08046031 in people with Malignant Melanoma and Melanoma, run by Pfizer at 11 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Spain, Sweden, United Kingdom. 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?
The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: through 30 days after the last study treatment; approximately 6 months). The study lists 3 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 18 Mar 2026.