Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT06779851
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate changes in immune cell composition and tumor genome.', 'timeFrame': 'Through study completion up to 2 years', 'description': 'Peripheral blood and/or tumour biopsy specimens may be analysed in an exploratory manner to assess changes in immune cell composition through immunophenotyping and cytokine level measurements.'}], 'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)', 'timeFrame': 'Duration of first cycle (28 Days) for each cohort evaluated', 'description': 'The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs'}, {'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'Through end of study (up to 2 years)', 'description': 'Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameter - Maximum Concentration (Cmax)', 'timeFrame': 'Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)', 'description': 'Maximum concentration of BPT567'}, {'measure': 'Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)', 'timeFrame': 'Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)', 'description': 'Time to maximum concentration of BPT567'}, {'measure': 'Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)', 'timeFrame': 'Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)', 'description': 'Terminal elimination half-life of BPT567'}, {'measure': 'Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))', 'timeFrame': 'Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)', 'description': '(AUC)0-last of BPT567'}, {'measure': 'Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)', 'timeFrame': 'Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)', 'description': 'AUC0-inf of BPT567'}, {'measure': 'Anti-drug Antibody (ADA) Response to BPT567', 'timeFrame': 'Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)', 'description': 'Number of Participants With Anti-drug Antibody (ADA) Response to BPT567'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through study completion up to 2 years', 'description': 'Per RECIST V1.1'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Through study completion up to 2 years', 'description': 'Per RECIST V1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Through study completion up to 2 years', 'description': 'Per RECIST V1.1'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Through study completion up to 2 years', 'description': 'Per RECIST V1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Tumors'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥18 years at the time of signing informed consent form\n* Measurable disease per RECIST 1.1\n* Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.\n* ECOG Performance status of 0 or 1\n* Life expectancy of at least 3 months\n* Adequate organ and marrow function\n* Contraception during study participation, as applicable\n\nExclusion Criteria:\n\n* Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.\n* Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.\n* Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.\n* Treatment with another IL-18 therapy.\n* Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.\n* Certain clinically significant intercurrent disease.\n* Primary immune deficiency.\n* Active untreated brain or spine metastasis or leptomeningeal metastases.\n* Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted.\n* Active hepatitis A or acute or chroming hepatitis B or C infection.\n* Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.'}, 'identificationModule': {'nctId': 'NCT06779851', 'acronym': 'SUMMIT-1', 'briefTitle': 'A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bright Peak Therapeutics Inc'}, 'officialTitle': 'A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'BPT567-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a Dose Escalation', 'description': 'Study drug BPT567 at multiple dose levels to define MTD or MAD', 'interventionNames': ['Drug: BPT567']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Expansion', 'description': 'Study drug BPT567 at recommended dose for expansion (RDE) cohorts', 'interventionNames': ['Drug: BPT567']}], 'interventions': [{'name': 'BPT567', 'type': 'DRUG', 'description': 'Immunocytokine infusion', 'armGroupLabels': ['Phase 1a Dose Escalation', 'Phase 1b Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Honor Health Research Institute (HRI) Nurse Navigation', 'role': 'CONTACT'}, {'role': 'CONTACT', 'phone': '480-323-1364'}], 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Burns, BS', 'role': 'CONTACT', 'email': 'Julie.burns@startresearch.com'}], 'facility': 'Start Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oncology Clinical Research Referral Office', 'role': 'CONTACT', 'email': 'OncologyResearchReferral@hmhn.org', 'phone': '551-996-1777'}], 'facility': 'Hackensack Meridian John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Neel Gandhi, MD', 'role': 'CONTACT'}], 'facility': 'Carolina BioOncology Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Long, RN, BSN, OCN', 'role': 'CONTACT', 'email': 'anne.long@providence.org', 'phone': '503-215-3577'}], 'facility': 'Providence Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr. Jason Luke', 'role': 'CONTACT', 'email': 'iddcreferrals@upmc.edu', 'phone': '412-648-6575'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel Jimenez Intake Specialist, RN, MSN', 'role': 'CONTACT', 'email': 'isabel.jimenez@startresearch.com', 'phone': '210-593-5265'}], 'facility': 'South Texas Accelerated Research Therapeutics (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Sujatha Venugopal Prasad, M. Sc.', 'role': 'CONTACT', 'email': 'sprasad@brightpeaktx.com', 'phone': '+1(408)357- 4546'}, {'name': 'Suba Krishnan, MD', 'role': 'CONTACT', 'email': 'skrishnan@brightpeaktx.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bright Peak Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}