Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 10:28 AM
Study NCT ID:
NCT06974734
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D021441', 'term': 'Carcinoma, Pancreatic Ductal'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation and expansion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 399}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention'}, {'measure': 'Number of participants with laboratory abnormalities', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years'}, {'measure': 'Number of dose modifications due to AEs', 'timeFrame': 'Through end of treatment up to approximately 2 years'}, {'measure': 'Number of participants with dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Number of participants with DLTs by dose level', 'timeFrame': 'Up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'PK endpoint'}, {'measure': 'PK parameter - Maximum concentration (Cmax)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'PK endpoint'}, {'measure': 'PK parameter - Time to maximum concentration (Tmax)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'PK endpoint'}, {'measure': 'PK parameter - t1/2', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'PK endpoint'}, {'measure': 'PK parameter - Trough concentration (Ctrough)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years', 'description': 'PK endpoint'}, {'measure': 'Number of participants with antidrug antibodies (ADAs)', 'timeFrame': 'Through 30-37 days after the last study treatment, up to approximately 2 years'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.'}, {'measure': 'Best overall response', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'PFS is defined as the time from start of PF-08046037 to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'OS is defined as the time from start of PF-08046037 to date of death due to any cause'}, {'measure': 'Percent change of cells within tumors based on multiplex immunofluorescence', 'timeFrame': 'Through end of study and up to approximately 2 years', 'description': 'This measure will assess the number of immune cells, PD-1, PD-L1, and TLR7 expression within the tumor microenvironment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced solid tumors', 'NSCLC', 'PDAC', 'HNSCC', 'ISAC', 'ADC', 'PD-L1 inhibitor'], 'conditions': ['Carcinoma, Non Small Cell Lung', 'Carcinoma, Pancreatic Ductal', 'Malignant Melanoma', 'Squamous Cell Carcinoma of the Head and Neck (SCCHN)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5941001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies.\n\nThis study is seeking participants who:\n\n* have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC);\n* are able to provide tumor tissue samples;\n* have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks.\n\nParticipants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.\n\n1. Tumor types\n\n * Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts\n\n * Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC\n * Must have progressive disease following at least 1 prior approved systemic therapy\n * Monotherapy Dose Expansion (Part 3a)\n\n • Advanced or metastatic NSCLC or PDAC\n * Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)\n\n * Advanced or metastatic NSCLC or HNSCC\n * May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy\n * Combination Dose Expansion (Part 3b)\n\n * Unresectable locally advanced or metastatic HNSCC or NSCLC\n * Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting)\n * Must be treatment naïve to any immunotherapy\n * NSCLC must have PD-L1 expression TPS \\>=50%\n * HNSCC must have PD-L1 expression CPS \\>=1\n2. Tissue requirement\n\n * Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory\n * Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment\n * Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required\n * Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment\n * Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor\n3. Measurable disease per RECIST v1.1\n\nParticipants who meet the following might not be able to participate.\n\n1. History of Grade \\>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy\n2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent\n3. History of uveitis within the preceding 6 months\n4. Clinically significant Grade \\>=3 neurodegenerative disease\n5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy\n6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist'}, 'identificationModule': {'nctId': 'NCT06974734', 'briefTitle': 'A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES', 'orgStudyIdInfo': {'id': 'C5941001'}, 'secondaryIdInfos': [{'id': '2025-521499-69-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a', 'description': 'PF-08046037 monotherapy dose escalation', 'interventionNames': ['Drug: PF-08046037']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2a', 'description': 'PF-08046037 monotherapy dose optimization', 'interventionNames': ['Drug: PF-08046037']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3a', 'description': 'PF-08046037 monotherapy dose expansion', 'interventionNames': ['Drug: PF-08046037']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1b', 'description': 'PF-08046037 +sasanlimab dose escalation', 'interventionNames': ['Drug: PF-08046037', 'Drug: sasanlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2b', 'description': 'PF-08046037 + sasanlimab dose optimization', 'interventionNames': ['Drug: PF-08046037', 'Drug: sasanlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3b', 'description': 'PF-08046037 + sasanlimab dose expansion', 'interventionNames': ['Drug: PF-08046037', 'Drug: sasanlimab']}], 'interventions': [{'name': 'PF-08046037', 'type': 'DRUG', 'otherNames': ['SGN-PDL1iT'], 'description': 'Given into the vein (IV; intravenous)', 'armGroupLabels': ['Part 1a', 'Part 1b', 'Part 2a', 'Part 2b', 'Part 3a', 'Part 3b']}, {'name': 'sasanlimab', 'type': 'DRUG', 'otherNames': ['PF-06801591'], 'description': 'Given under the skin (SQ; subcutaneous)', 'armGroupLabels': ['Part 1b', 'Part 2b', 'Part 3b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Presbyterian/ St. Lukes Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at HealthONE', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Smilow Cancer Hospital - Yale New Haven Health', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale - New Haven Hospital - Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Smilow Cancer Hospital Phase 1 Unit', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Smilow Cancer Hospital - Trumbull', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '46219', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network, Inc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UPMC Vision Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UPMC Presbyterian Shadyside Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute - Pharmacy', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tristar Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'START San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '00935', 'city': 'Rio Piedras', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'Pan American Center for Oncology Trials, LLC', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}], 'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], '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'}}}}