Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:37 PM
Study NCT ID:
NCT06799533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'single group assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'through 30 days after the last study treatment; approximately 6 months', 'description': '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.'}, {'measure': 'Number of participants with laboratory abnormalities', 'timeFrame': 'through 30days after the last study treatment; approximately 6 months'}, {'measure': 'Number of participants with dose limiting toxicities', 'timeFrame': 'up to 28 days'}], 'secondaryOutcomes': [{'measure': 'number of participants with antidrug antibodies', 'timeFrame': 'through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'Pharmacokinetic (PK) parameter - Area under the curve (AUC)', 'timeFrame': 'Through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'PK parameter - Maximum Concentration (Cmax)', 'timeFrame': 'Through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'PK parameter - Time to maximum concentration (Tmax)', 'timeFrame': 'Through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'PK parameter - Apparent terminal half-life (t1/2)', 'timeFrame': 'Through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'PK parameter - Trough concentration (Ctrough)', 'timeFrame': 'Through 30 days after the last study treatment; approximately 6 months', 'description': 'To be summarized using descriptive statistics'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to approximately 1 year', 'description': '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'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to approximately 1 year', 'description': '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'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to approximately 1 year', 'description': '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'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately 2 years', 'description': 'The time from the start of study treatment to death due to any cause'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid tumors', 'Other Solid tumors'], 'conditions': ['Malignant Melanoma', 'Melanoma', 'Metastatic Melanoma', 'Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5901001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n\nEastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline\n\n• Participants who have refused available standard of care therapies are not eligible.\n\nExclusion Criteria:\n\n• 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.\n\nMelanoma 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\n\n• 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.\n\nOther protocol specific criteria might apply.'}, 'identificationModule': {'nctId': 'NCT06799533', 'briefTitle': 'A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS', 'orgStudyIdInfo': {'id': 'C5901001'}, 'secondaryIdInfos': [{'id': '2024-514745-10-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-08046031 monotherapy', 'description': 'PF-08046031', 'interventionNames': ['Drug: PF-08046031']}], 'interventions': [{'name': 'PF-08046031', 'type': 'DRUG', 'description': 'Given into the vein (IV; intravenous)', 'armGroupLabels': ['PF-08046031 monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center, Investigational Pharmacy', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at HealthONE - SCRI - PPDS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Val-de-marne', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [barcelona]', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '171 64', 'city': 'Solna', 'state': 'Stockholms LÄN [se-01]', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset Solna', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'w1g 6ad', 'city': 'London', 'state': 'London, CITY of', 'country': 'United Kingdom', 'facility': 'Sarah Cannon Research Institute UK', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}