Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:09 PM
Study NCT ID:
NCT07450859
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DoR) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'The time from the first documentation of a tumor response (that is subsequently confirmed) to the first documentation of disease progression or death per RECIST v1.1'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years', 'description': 'The length of time from the first day of study treatment (Day 1) to day of death'}, {'measure': 'Disease Control Rate (DCR) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'Percentage of participants who achieve a confirmed CR, PR, or stable disease (SD) per RECIST v1.1'}, {'measure': 'Clinical Benefit Rate (CBR) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'Defined as the proportion of participants with CR, PR, or SD ≥12 weeks per RECIST v1.1'}, {'measure': 'Progression-Free Survival (PFS) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'The time from the first day of study treatment to the first documentation of disease progression or death per RECIST v1.1'}, {'measure': 'Time to Progression (TTP) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years', 'description': 'TTP defined as the time from first dose of BT5528 until date of first documentation of disease progression per RECIST v1.1'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants experiencing an adverse event on treatment'}, {'measure': 'Incidence of treatment emergent serious adverse events (TESAEs)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants experiencing serious adverse events on treatment'}, {'measure': 'Incidence of laboratory abnormalities', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants that experience abnormal laboratory values (blood chemistry (including liver function tests and creatinine clearance), hematology (including hemoglobin, neutrophil and platelet absolute counts)) on treatment'}, {'measure': 'Incidence of ECG abnormalities', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants that experience abnormal ECG parameters on treatment'}, {'measure': 'Incidence of abnormal vital signs', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants that have changes in vital signs such as blood pressure, heart rate, oxygen saturation, respiratory rate, and body temperature on treatment'}, {'measure': 'Incidence of treatment modification due to adverse events', 'timeFrame': 'Up to approximately 3 years', 'description': 'Proportion of participants that require any treatment modification due to adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'BT5528', 'EphA2', 'Bicycle Drug Conjugate', 'MMAE', 'Metastatic', 'Pancreatic Ductal Adenocarcinoma', 'PDAC'], 'conditions': ['Pancreatic Ductal Adenocarcinoma (PDAC)']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 study for BT5528 in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment.\n\nThe drug, BT5528, is designed to find a specific protein called EphA2.\n\nThe main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive BT5528, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.', 'detailedDescription': 'This is a Phase 2, open-label, multicenter, single-arm study to evaluate the efficacy, safety, and pharmacokinetics (PK) of BT5528 in adult participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after one prior line of systemic therapy. BT5528 is a novel Bicycle® drug conjugate (BDC®) that targets EphA2, a protein often found on cancer cells, and delivers a potent anti-cancer agent (MMAE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* At least 18 years of age at the time of signature of the informed consent form\n* Measurable disease as defined by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy of at least 12 weeks\n* Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC)\n* Participants must have failed only 1 prior line of therapy with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors is permitted\n* Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers\n* Adequate organ function (hematologic, renal, and hepatic)\n* Negative pregnancy test for participants of childbearing potential (POCBP)\n* Must be willing and able to comply with the protocol and study procedures\n\nExclusion Criteria\n\n* Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment\n* Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of BT5528 study treatment\n* Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent\n* Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy\n* Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0\n* Untreated central nervous system (CNS) metastases\n\nNote: Additional protocol defined Inclusion/Exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT07450859', 'briefTitle': 'A Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BicycleTx Limited'}, 'officialTitle': 'A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'BT5528-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BT5528 Monotherapy', 'interventionNames': ['Drug: BT5528']}], 'interventions': [{'name': 'BT5528', 'type': 'DRUG', 'description': 'Participants will receive BT5528 via intravenous (IV) infusion every 2 weeks (Q2W)', 'armGroupLabels': ['BT5528 Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'BicycleTx Limited', 'role': 'CONTACT', 'email': 'clinicalstudies@bicycletx.com', 'phone': '617-945-8155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BicycleTx Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}