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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003862-37 | EudraCT Number |
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Business Decision
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DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor. |
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| Cohort 2 | Experimental | Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy. |
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| Cohort 3 | Experimental | Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITIL-168 | Biological | ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review. | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | For subjects who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death. | Up to 60 months |
| Progression-free Survival |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Instil Study Director | Instil Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego, Moores Cancer Center | La Jolla | California | 92093 | United States | ||
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All enrolled participants are assigned to be treated with a single dose of ITIL-168
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Progression-free survival (PFS) is defined as the time from the ITIL-168 infusion date to the date of disease progression or death from any cause.
| Up to 60 months |
| Overall Survival | Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause. | Up to 60 months |
| ORR as determined by investigators | ORR as determined by investigators is defined as the incidence of a CR or a PR per a modified RECIST v1.1, as determined by study investigators. | Up to 60 months |
| Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest | Up to 60 months |
| Disease Control Rate | Disease control rate (DCR), defined as the incidence of CR, PR, or stable disease (SD) per a modified RECIST v1.1 criteria, as determined by central review. | Up to 60 months |
| Best Overall Response | Up to 60 months |
| Time to Response | Up to 60 months |
| The Angeles Clinic and Research Institute |
| Los Angeles |
| California |
| 90025 |
| United States |
| USC - Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| UCLA Health - Westwood Cancer Care | Los Angeles | California | 90095 | United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| University of Colorado - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| The University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Rush University Cancer Center | Chicago | Illinois | 60612 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Minnesota, Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Atlantic Health System - Morristown Medical Center | Morristown | New Jersey | 07962 | United States |
| Cleveland Clinic - Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital | Cambridge | England | CB2 0QQ | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2024 | May 15, 2024 | 18 | ||
| May 21, 2024 | Jun 11, 2024 | 19 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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