Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-04 @ 9:58 PM
Study NCT ID:
NCT06440005
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2024-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006394', 'term': 'Hemangiosarcoma'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-05-26', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptable maximum tolerated dose for participants', 'timeFrame': '21 days following the first dose of AGX101 (Day 1 through Day 21)', 'description': 'Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Screening through end of treatment, approximately 6 months and up to 3 years', 'description': 'Evaluation of the incidence, severity, and duration of adverse events'}], 'secondaryOutcomes': [{'measure': 'Terminal elimination half life (PK)', 'timeFrame': '22 days following the first dose of AGX101 (Day 1 through Day 22)', 'description': 'Determination of the terminal elimination half-life (t½)'}, {'measure': 'AUC (PK)', 'timeFrame': '22 days following the first dose of AGX101 (Day 1 through Day 22)', 'description': 'Determination of the AUC in 1 dosing interval'}, {'measure': 'Cmax (PK)', 'timeFrame': '22 days following the first dose of AGX101 (Day 1 through Day 22)', 'description': 'Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state'}, {'measure': 'Number of Participants with Antidrug Antibodies (ADA) to AGX101', 'timeFrame': 'Approximately 6 months and up to 3 years', 'description': 'Incidence and titers of ADA will be measured'}, {'measure': 'Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator', 'timeFrame': 'Approximately 6 months and up to 3 years', 'description': 'Determination the objective response rate (ORR)'}, {'measure': 'Efficacy as measured by Duration of Response (DoR) Assessed by Investigator', 'timeFrame': 'Approximately 6 months and up to 3 years', 'description': 'Determination of the duration of response (DoR)'}, {'measure': 'Efficacy as measured by Disease Control Rate (DCR)', 'timeFrame': 'Approximately 6 months and up to 3 years', 'description': 'Determination of the disease control rate (DCR)'}, {'measure': 'Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator', 'timeFrame': 'Approximately 6 months and up to 3 years', 'description': 'Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).'}, {'measure': 'Efficacy as measured by Duration of Treatment', 'timeFrame': 'Approximately 6 months and up to 3 years'}, {'measure': 'Overall Survival', 'timeFrame': 'Approximately 6 months and up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADC', 'Antibody Drug Conjugate', 'AGX101'], 'conditions': ['Cancer', 'Advanced Cancer', 'Locally Advanced Carcinoma', 'Metastatic Solid Tumor', 'Breast Cancer', 'Prostate Cancer', 'Colorectal Cancer', 'Pancreatic Cancer', 'Liver Cancer', 'Angiosarcoma', 'Solid Tumor']}, 'descriptionModule': {'briefSummary': 'AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.\n\nDosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.\n* Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor\n* Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life\n* Have an ECOG performance status of 0 to 1\n* Have adequate organ function\n* LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan\n* Highly effective contraception for both male and female patients throughout the study\n\nExclusion Criteria:\n\n* Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed)\n* Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)\n* Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment\n* Significant (ie, ≥ Grade 2) ocular disturbances\n* Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding\n* Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation\n* Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis\n* Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment\n* Has received prior radiotherapy within 2 weeks prior to starting study treatment\n* Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response\n* Clinically significant cardiovascular disease\n* Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication\n* Has an active infection requiring concurrent systemic antibiotic therapy\n* A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment\n* Is breastfeeding or expecting to conceive or father children within the projected duration of the study'}, 'identificationModule': {'nctId': 'NCT06440005', 'briefTitle': 'A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiex, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'AGX101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Phase', 'description': 'AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma.', 'interventionNames': ['Drug: AGX101']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Phase', 'description': 'AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.', 'interventionNames': ['Drug: AGX101']}], 'interventions': [{'name': 'AGX101', 'type': 'DRUG', 'otherNames': ['ADC'], 'description': 'Antibody Drug Conjugate', 'armGroupLabels': ['Dose Escalation Phase', 'Dose Expansion Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Beaman', 'role': 'CONTACT', 'email': 'becky.beaman@scri.com'}, {'name': 'Meredith P Pelster, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarah Cannon Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Betancourt', 'role': 'CONTACT', 'email': 'abetancourt@nextoncology.com'}, {'name': 'Ismael Rodriguez Rivera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Patterson', 'role': 'CONTACT', 'phone': '703-783-4505'}, {'name': 'Alexander Spira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Glen Weiss, MD', 'role': 'CONTACT', 'email': 'trials@angiex.com', 'phone': '857-203-7808'}], 'overallOfficials': [{'name': 'Glen Weiss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Lead'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiex, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}