Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-13 @ 9:32 PM
Study NCT ID:
NCT07007559
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712178', 'term': 'ALX148'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C490954', 'term': 'eribulin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a basket study with substudies based on indications.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MBC substudy: Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer. ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 based on BICR assessment.'}], 'secondaryOutcomes': [{'measure': 'MBC substudy: Overall Response Rate (ORR) based on Investigator assessment', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer by levels of CD47 expression. ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) based on Investigator Assessment.'}, {'measure': 'MBC substudy: Clinical Benefit Rate (CBR) using RECIST v1.1 based on BICR and Investigator assessment', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the CBR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer. CBR is defined as the proportion of participants whose BOR is confirmed PR, confirmed CR, or SD with duration \\>6 months using RECIST v1.1 based on BICR and Investigator assessment.'}, {'measure': 'MBC substudy: Duration of Response (DoR) using RECIST v1.1 based on BICR and Investigator assessment', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the DoR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer. DoR is measured from the time measurement criteria are first met for CR / PR (whichever is first recorded) until documented progressive disease or death from any cause, whichever occurs first using RECIST v1.1 based on BICR and Investigator assessment.'}, {'measure': 'MBC substudy: Progression-Free Survival (PFS) using RECIST v1.1 based on BICR and Investigator assessment', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the PFS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer. PFS is measured from the date of enrollment until documented progressive disease or death from any cause, whichever occurs first, using RECIST v1.1 based on BICR and Investigator assessment'}, {'measure': 'MBC substudy: Overall Survival (OS)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Evaluate the OS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive ctDNA-positive breast cancer. OS is defined as the time from the date of enrollment until death.'}, {'measure': 'MBC substudy: Number of participants with adverse events (AEs) and with laboratory abnormalities', 'timeFrame': 'Enrollment to 28 days after the last administration of the study drug', 'description': 'AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity, and timing.'}, {'measure': 'All substudies: Maximum Concentration (Cmax)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'To evaluate the Cmax of evorpacept'}, {'measure': 'All substudies: Time at Maximum Concentration (Tmax)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'To evaluate the Tmax of evorpacept'}, {'measure': 'All substudies: Area under the Concentration-Time Curve (AUC)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'To evaluate the AUC of evorpacept'}, {'measure': 'All substudies: Clearance (CL)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'To evaluate the CL of evorpacept'}, {'measure': 'All substudies: Terminal elimination half-life (t1/2)', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'To evaluate the t1/2 of evorpacept'}, {'measure': 'All substudies: Evaluate the immunogenicity of evorpacept', 'timeFrame': 'Approximately 6 months after the last participant is enrolled', 'description': 'Measured by presence of human serum ADA (anti-evorpacept antibodies)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic', 'Her2+', 'metastatic HER2-positive breast cancer', 'breast cancer', 'HER2-positive', 'Evorpacept', 'CD47', 'ERBB2', 'Enhertu', 'trastuzumab deruxtecan', 'ASPEN-09', 'Herceptin', 'solid tumors', 'trastuzumab', 'ALX148', 'mBC', 'ASPEN-Breast'], 'conditions': ['Breast Cancer, Metastatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:\n\n* Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.\n* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.\n* Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.', 'detailedDescription': 'Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor.\n\nNot all substudies may be active and/or open to enrollment at a given time. Not all study centers may be participating in every substudy. MBC substudy will be the first to enroll - thus the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria only include MBC at this time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all substudies):\n\n* Participants must have at least one measurable lesion as defined by RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.\n* Life expectancy of at least 3 months\n* Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment\n\nMBC substudy:\n\n* Histologically confirmed invasive HER2 positive breast cancer\n* Available tumor tissue (FFPE slides or block). A fresh biopsy is preferred but optional.\n* Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease.\n* Progressed on or following the most recent line of therapy\n* Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)\n* LVEF ≥50%\n* Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation\n* Adequate liver function:\n* Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);\n* Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).\n\nExclusion Criteria (all substudies):\n\n* Participants with known CNS metastases unless treated and stable prior to enrollment\n* Following anti-cancer therapy with insufficient washout before C1D1:\n\n 1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of C1D1.\n 2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of C1D1)\n* Prior exposure to any anti-CD47 or anti-SIRPα agent.\n* History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.\n* Had an allogeneic tissue/solid organ transplant.\n* Any active, unstable cardiovascular disease\n* Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n\nMBC substudy:\n\n* Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen\n* Other primary malignancy within 2 years\n* Any condition that would be contraindicated to receiving trastuzumab'}, 'identificationModule': {'nctId': 'NCT07007559', 'acronym': 'ASPEN-09', 'briefTitle': 'ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALX Oncology Inc.'}, 'officialTitle': 'ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies', 'orgStudyIdInfo': {'id': 'AT148009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer', 'description': '* Evorpacept (IV) - once every 3 weeks (Q3W)\n* Trastuzumab (IV) - once every 3 weeks (Q3W)\n* Chemotherapy (physician selects one of the following):\n\n * Capecitabine (Oral) 14 days every 3 weeks\n * Eribulin (IV) twice every 3 weeks\n * Gemcitabine (IV) twice every 3 weeks\n * Paclitaxel (IV) once every 3 weeks (Q3W)\n * Vinolrebine (IV) twice every 3 weeks', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Trastuzumab', 'Drug: Paclitaxel', 'Drug: Capecitabine', 'Drug: Eribulin', 'Drug: Gemcitabine', 'Drug: Vinorelbine']}], 'interventions': [{'name': 'Evorpacept (ALX148)', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Oral administration', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Eribulin', 'type': 'DRUG', 'otherNames': ['Halaven'], 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'otherNames': ['Navelbine'], 'description': 'IV infusion', 'armGroupLabels': ['Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'HealthPartners Frauenshuh Cancer Center', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '402-334-4773'}], 'facility': 'Oncology Hematology West, Pc Dba Nebraska Cancer Specialists', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}], 'centralContacts': [{'name': 'Cheng Quah, MD', 'role': 'CONTACT', 'email': 'info@alxoncology.com', 'phone': '650-466-7125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALX Oncology Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}