A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors
NCT ID: NCT06799533
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
11 participants
INTERVENTIONAL
2025-05-01
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-08046031 monotherapy
PF-08046031
PF-08046031
Given into the vein (IV; intravenous)
Interventions
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PF-08046031
Given into the vein (IV; intravenous)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, United States
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, United States
Sarah Cannon Research Institute at HealthONE - SCRI - PPDS
Denver, Colorado, United States
Gustave Roussy
Villejuif, Val-de-marne, France
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01], Sweden
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Sarah Cannon Research Institute UK
London, London, CITY of, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-514745-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5901001
Identifier Type: -
Identifier Source: org_study_id