Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT06795412
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who Experience a Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Day 1 to Day 21'}, {'measure': 'Number of Participants who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number of Participants who Experience Clinically Significant Changes in Vital Signs', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Time to Response', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Maximum Observed Concentration (Cmax) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Time to Maximum Concentration (Tmax) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Clearance (CL) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Half-Life (t½) for Antibody-drug Conjugate (ADC)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Half-Life (t½) for Total Antibody (tAb)', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Half-Life (t½) for Free Payload', 'timeFrame': 'Day 1 up to approximately 2 years'}, {'measure': 'Incidence of Anti-PYX-201 Antibodies', 'timeFrame': 'Day 1 up to approximately 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumours', 'PYX-201', 'Pembrolizumab'], 'conditions': ['Advanced Solid Tumours']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.\n2. Male or non-pregnant, non-lactating female participants age ≥18 years.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.\n5. Life expectancy of \\>3 months, in the opinion of the Investigator.\n6. Adequate hematologic function.\n7. Adequate hepatic function.\n8. Adequate renal function.\n9. Adequate coagulation profile.\n10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.\n\nExclusion Criteria\n\n1. Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n3. Significant cardiovascular disease within 6 months prior to start of study drug.\n4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.\n5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n6. Failure to recover to Baseline severity or National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.\n7. Participants with active neuropathy of any grade per CTCAE v5.0 at Screening.\n8. History of uncontrolled diabetes mellitus.\n9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.\n10. Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.\n11. Prior solid organ or bone marrow progenitor cell transplantation.\n12. Prior high-dose chemotherapy requiring stem cell rescue.\n13. Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.\n14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients."}, 'identificationModule': {'nctId': 'NCT06795412', 'briefTitle': 'Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pyxis Oncology, Inc'}, 'officialTitle': 'A Phase 1/2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PYX-201-102'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-G17', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': 'MK-3475-G17', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Dose Escalation', 'description': 'Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.', 'interventionNames': ['Drug: PYX-201', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Dose Expansion', 'description': 'Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.', 'interventionNames': ['Drug: PYX-201', 'Drug: pembrolizumab']}], 'interventions': [{'name': 'PYX-201', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Dose Escalation', 'Part 2: Dose Expansion']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®'], 'description': 'IV infusion.', 'armGroupLabels': ['Part 1: Dose Escalation', 'Part 2: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarcoma Oncology Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas - M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Pyxis Oncology Clinical Trial Team', 'role': 'CONTACT', 'email': 'clinicaltrials@pyxisoncology.com', 'phone': '617-453-3596'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pyxis Oncology, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}