[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06060613":3,"trial-entities:NCT06060613":228,"trial-summary:NCT06060613":234},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":35,"interventions":38,"primary_outcomes":45,"secondary_outcomes":56,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":78,"locations":81,"central_contacts":220,"overall_officials":225,"references":226,"see_also_links":227},"NCT06060613","OBX115-23-01","Safety and Efficacy of OBX-115 in Advanced Solid Tumors","A Phase 1\u002F2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors","RECRUITING","2029-06-30","2026-07","2026-07-16","2023-10-25","Obsidian Therapeutics, Inc.","INDUSTRY",false,"This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.","Primary Objective (Phase 1):\n\n• Assess the safety and tolerability of OBX-115 regimen\n\nPrimary Objective (Phase 2):\n\n* Evaluate preliminary efficacy of OBX-115 regimen as measured by Blinded Independent Central Review (BICR) using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohort 3)\n* Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohorts 1, 2, 4)\n\nSecondary (Phase 1):\n\n• Assess preliminary efficacy of OBX-115 regimen by evaluating ORR\n\nSecondary (Phase 2):\n\n• Evaluate safety and tolerability of OBX 115 based on the collected AE data\n\nSecondary (both Phase 1 and Phase 2):\n\n* Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by BICR until disease progression or death due to cancer (Phase 2 Cohort 3).\n* Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to cancer (Phase 1 and Phase 2 Cohorts 1, 2, and 4).\n* Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by BICR (Phase 2 Cohort 3).\n* Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator (Phase 1 and Phase 2 Cohorts 1, 2, and 4).\n* Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by BICR or death due to any cause (Phase 2 Cohort 3).\n* Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause (Phase 1 and Phase 2 Cohorts 1, 2, and 4).\n* Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause\n* Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.",[19,20,21,22,23,24,25],"Tumor Skin","Metastatic Melanoma","Melanoma","Lung Cancer","Metastatic Lung Cancer","Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[27,28,29,21,22],"Adoptive cell therapy","Tumor Infiltrating Lymphocytes","TIL","INTERVENTIONAL","TREATMENT",[33,34],"PHASE1","PHASE2",{"count":36,"type":37},208,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43},"BIOLOGICAL","OBX-115","A tumor sample is obtained from each participant for autologous OBX-115 manufacture.\n\nAfter lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.",[44],"Participants with advanced solid tumors",[46,50,54],{"measure":47,"description":48,"timeFrame":49},"Incidence and nature of dose-limiting toxicities (DLTs)","• Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).","28 Days",{"measure":51,"description":52,"timeFrame":53},"The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1","• The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 3)","2 years",{"measure":51,"description":55,"timeFrame":53},"• The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 1, 2, and 4)",[57,60],{"measure":58,"description":59,"timeFrame":53},"The proportion of participants who have a confirmed CR or PR per RECIST v1.1","• The proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 1)",{"measure":61,"description":62,"timeFrame":53},"Incidence of AEs","• Incidence of treatment-emergent adverse events (TEAEs), including SAEs, study intervention related AEs, and AEs leading to early discontinuation of study intervention or withdrawal from the Assessment Period or death up to 2 years after initiation of study intervention","ALL","18 Years",null,{"inclusion":67,"exclusion":76,"raw_text":77},[68,69,70,71,68,72,73,74,75],"Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.","Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody. 2. Phase 1 and Phase 2 Cohort 2 (recruiting):","Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and\u002For an approved targeted therapy for known molecular abnormalities if applicable to their disease).","Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting. 3. Phase 2 Cohort 3 (recruiting):","Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.","Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF\u002FMEK inhibitor that was given as the most recent line of therapy. 4. Phase 2 Cohort 4 (recruiting):","Participants with frontline unresectable or metastatic melanoma.","Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression.) Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible. 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation. 5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months. 7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\]). 8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery. 9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and\u002For abstinence requirements. 10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count. 11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.",[],"Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing the informed consent.\n2. Participant has a histologically confirmed diagnosis of advanced\u002Fmetastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).\n3. Cohort and indication specific criteria as follows:\n\n   1. Phase 1 and Phase 2 Cohort 1 (enrollment complete):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n   2. Phase 1 and Phase 2 Cohort 2 (recruiting):\n\n      * Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and\u002For an approved targeted therapy for known molecular abnormalities if applicable to their disease).\n      * Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting.\n   3. Phase 2 Cohort 3 (recruiting):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n      * Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF\u002FMEK inhibitor that was given as the most recent line of therapy.\n   4. Phase 2 Cohort 4 (recruiting):\n\n      * Participants with frontline unresectable or metastatic melanoma.\n      * Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression.) Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible.\n4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.\n5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.\n7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\]).\n8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.\n9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and\u002For abstinence requirements.\n10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.\n11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).\n2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.\n3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.\n4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.\n5. Participant has any form of primary or acquired immunodeficiency.\n6. Participant has a history of hypersensitivity to any component of the study intervention.\n7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).\n8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.\n9. Participant requires systemic steroid therapy of greater than10 mg\u002Fday of prednisone or equivalent.\n10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).\n11. Participant has evidence of positive infectious disease screening and\u002For any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.",[79,80],"ADULT","OLDER_ADULT",[82,99,110,124,139,153,168,177,191,205],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"The Angeles Clinic and Research Institute (Melanoma)","Los Angeles","California","90025","United States",[89,93],{"name":90,"role":91,"email":92},"Saba Mukarram","CONTACT","SMukarram@theangelesclinic.org",{"name":94,"role":95},"Omid Hamid, MD","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},34.05223,-118.24368,{"facility":100,"status":8,"city":84,"state":85,"zip":101,"country":87,"contacts":102,"geoPoint":109},"USC Norris Comprehensive Cancer Center (Melanoma\u002FNSCLC)","90033",[103,107],{"name":104,"role":91,"phone":105,"email":106},"Sandy Tran","323-865-3935","sandy.tran@med.usc.edu",{"name":108,"role":95},"Gino In, MD",{"lat":97,"lon":98},{"facility":111,"status":8,"city":112,"state":85,"zip":113,"country":87,"contacts":114,"geoPoint":121},"Stanford Cancer Institute (Melanoma\u002FNSCLC)","Stanford","94305",[115,119],{"name":116,"role":91,"phone":117,"email":118},"Samantha Lam","650-736-3054","samalam@stanford.edu",{"name":120,"role":95},"Allison Betof, MD",{"lat":122,"lon":123},37.42411,-122.16608,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":87,"contacts":129,"geoPoint":136},"Orlando Health Cancer Institute (Melanoma\u002FNSCLC)","Orlando","Florida","32806",[130,134],{"name":131,"role":91,"phone":132,"email":133},"Danielle Ramos","321-841-6764","danielle.ramos1@orlandohealth.com",{"name":135,"role":95},"Tirrell T. Johnson, MD",{"lat":137,"lon":138},28.53834,-81.37924,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":87,"contacts":144,"geoPoint":150},"James Graham Brown Cancer Center (Melanoma\u002FNSCLC)","Louisville","Kentucky","40202",[145,148],{"name":146,"role":91,"email":147},"Melissa B. Hall","Mmbaro01@louisville.edu",{"name":149,"role":95},"Jason Chesney, MD, PhD",{"lat":151,"lon":152},38.25424,-85.75941,{"facility":154,"status":8,"city":155,"state":155,"zip":156,"country":87,"contacts":157,"geoPoint":165},"Memorial Sloan Kettering (Melanoma\u002FNSCLC)","New York","10065",[158,160,163],{"name":21,"role":91,"phone":159},"6464979067",{"name":161,"role":91,"phone":162},"NSCLC","6464979163",{"name":164,"role":95},"Alexander Shoushtari, MD",{"lat":166,"lon":167},40.71427,-74.00597,{"facility":169,"status":170,"city":171,"state":172,"zip":173,"country":87,"geoPoint":174},"The Ohio State University","ACTIVE_NOT_RECRUITING","Columbus","Ohio","43210",{"lat":175,"lon":176},39.96118,-82.99879,{"facility":178,"status":8,"city":179,"state":180,"zip":181,"country":87,"contacts":182,"geoPoint":188},"Allegheny Research Institute (Melanoma\u002FNSCLC)","Pittsburgh","Pennsylvania","15224",[183,186],{"name":184,"role":91,"email":185},"Lindsay Brown","lindsey.brown@ahn.org",{"name":187,"role":95},"Deanna Huffman, DO",{"lat":189,"lon":190},40.44062,-79.99589,{"facility":192,"status":8,"city":193,"state":194,"zip":195,"country":87,"contacts":196,"geoPoint":202},"M.D. Anderson Cancer Center (Melanoma\u002FNSCLC)","Houston","Texas","77030",[197,200],{"name":198,"role":91,"email":199},"Steffy Jose","SJose3@mdanderson.org",{"name":201,"role":95},"Rodabe Amaria, MD",{"lat":203,"lon":204},29.76328,-95.36327,{"facility":206,"status":8,"city":207,"state":208,"zip":209,"country":210,"contacts":211,"geoPoint":217},"Melanoma Institute of Australia","Wollstonecraft","New South Wales","2065","Australia",[212,215],{"name":213,"role":91,"email":214},"Natalie Salatino","Natalie.Salatino@melanoma.org.au",{"name":216,"role":95},"Georgina Long, MD",{"lat":218,"lon":219},-33.8328,151.18981,[221],{"name":222,"role":91,"phone":223,"email":224},"Obsidian Therapeutics","781-202-5423","OBX115-2301TRIAL@OBSIDIANTX.COM",[],[],[],{"nct_id":4,"conditions":229,"biomarkers":232},[230,21,231],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[233],"BRAF Gene",{"nct_id":4,"found":235,"summary":236,"prompt_version":246},true,{"design":237,"status":238,"heading":239,"summary":240,"follow_up":241,"word_count":242,"commitments":243,"compensation":244,"drugs_mentioned":245},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 208 participants.","completed","OBX-115 for Advanced Solid Tumors","This study is testing a treatment called OBX-115 for adults with advanced melanoma (a type of skin cancer) or advanced non-small cell lung cancer. Researchers want to see how safe OBX-115 is and if it can shrink tumors. To participate, a tumor sample will be taken from you to create your personalized OBX-115 treatment. You will then receive OBX-115 after a preparation treatment with cyclophosphamide and fludarabine, followed by short courses of acetazolamide. The study will measure how many participants have their tumors shrink or disappear completely. There are 208 participants planned for this study.","The study will track your response to treatment for up to 2 years.",95,"You will have a tumor sample taken to create your personalized OBX-115. You will then receive a preparation treatment (lymphodepletion) followed by the OBX-115 infusion and short courses of acetazolamide.","Not stated in the trial record.",[41],"v2"]