Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 10:19 AM
Study NCT ID:
NCT05156866
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events and serious adverse events', 'timeFrame': 'up to 2 years', 'description': 'Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '28 Days', 'description': 'Highest administered dose with \\< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants'}, {'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'up to 2 years', 'description': 'Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'Time from CR or PR to objective disease progression or death to any cause'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'up to 2 years', 'description': 'Time from start of treatment to complete response or partial response'}, {'measure': '1 Year Overall Survival (1YOS)', 'timeFrame': '1 year', 'description': 'Proportion of participants alive at 1 year from the start of treatment to death from any cause'}, {'measure': '2 Year Overall Survival (2YOS)', 'timeFrame': '2 years', 'description': 'Proportion of participants alive at 2 years from the start of treatment to death from any cause'}, {'measure': 'Number of anti-drug antibody (ADA) Positive Participants', 'timeFrame': 'up to 2 years', 'description': 'Immunogenicity will be measured by the number of participants that are ADA positive.'}, {'measure': 'Maximum Serum Concentration of TORL-2-307-ADC (Cmax)', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Minimum Serum Concentration of TORL-2-307-ADC (Cmin)', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)', 'timeFrame': '21 days', 'description': 'PK Assessment'}, {'measure': 'Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)', 'timeFrame': '63 days', 'description': 'PK Assessment'}, {'measure': 'Terminal Half-life (t1/2) of Serum TORL-2-307-ADC', 'timeFrame': '63 days', 'description': 'PK Assessment'}, {'measure': 'Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-ADC', 'timeFrame': '21 days', 'description': 'PK Assessment'}, {'measure': 'Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-ADC', 'timeFrame': '63 days', 'description': 'PK Assessment'}, {'measure': 'Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC', 'timeFrame': '63 days', 'description': 'PK Assessment'}, {'measure': 'Clearance (CL) of TORL-2-307-ADC', 'timeFrame': '63 days', 'description': 'PK Assessment'}, {'measure': 'Accumulation ratio (Rac) of TORL-2-307-ADC', 'timeFrame': '63 days', 'description': 'PK Assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['claudin18.2'], 'conditions': ['Advanced Solid Tumor', 'Gastric Cancer', 'Pancreas Cancer', 'Gastroesophageal Junction Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '37788341', 'type': 'DERIVED', 'citation': "O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353."}]}, 'descriptionModule': {'briefSummary': 'This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced solid tumor\n* Measurable disease, per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Has not recovered \\[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements\n* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC\n* Progressive or symptomatic brain metastases\n* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection\n* History of significant cardiac disease\n* History of myelodysplastic syndrome (MDS) or AML\n* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded\n* If female, is pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05156866', 'briefTitle': 'First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'TORL Biotherapeutics, LLC'}, 'officialTitle': 'A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer', 'orgStudyIdInfo': {'id': 'TORL2307ADC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy Dose Dose Finding - Part 1', 'description': 'TORL-2-307-ADC', 'interventionNames': ['Drug: TORL-2-307-ADC']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion as Monotherapy - Part 2', 'description': 'TORL-2-307-ADC', 'interventionNames': ['Drug: TORL-2-307-ADC']}], 'interventions': [{'name': 'TORL-2-307-ADC', 'type': 'DRUG', 'description': 'antibody drug conjugate', 'armGroupLabels': ['Expansion as Monotherapy - Part 2', 'Monotherapy Dose Dose Finding - Part 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David J Park, MD', 'role': 'CONTACT'}], 'facility': 'Providence St. Jude Medical Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zev Wainberg, MD', 'role': 'CONTACT', 'phone': '310-586-2094'}], 'facility': 'UCLA - JCCC Clinical Research Unit', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hugo Hool, MD', 'role': 'CONTACT'}], 'facility': 'Torrance Memorial Medical', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sunil Babu, MD', 'role': 'CONTACT'}], 'facility': 'Fort Wayne Medical Oncology and Hematology', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '63310', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kian H Lim, MD', 'role': 'CONTACT'}, {'name': 'Kian Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine-Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vivian Cline, MD', 'role': 'CONTACT'}, {'name': 'Vivian Cline, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Oncology-Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Kitchens, MD', 'role': 'CONTACT'}, {'name': 'Benjamin Kitchens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Oncology-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Drew Rasco, MD', 'role': 'CONTACT'}, {'name': 'Drew Rasco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'START San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald Richards, MD', 'role': 'CONTACT'}, {'name': 'Donald Richards, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Oncology-Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Yong Kim', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sun Young Rha', 'role': 'CONTACT'}], 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '13620', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Keun Wook Lee', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ibrahim Qazi, PharmD', 'role': 'CONTACT', 'email': 'ibrahim.qazi@torlbio.com', 'phone': '310-348-9636'}], 'overallOfficials': [{'name': 'Ibrahim Qazi, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'TORL Biotherapeutics, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TORL Biotherapeutics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Translational Research in Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}