Back to resultsITIL-168 in Advanced Solid Tumors (DELTA-2)
Primary Purpose
Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ITIL-168
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring ITIl-168, Cell Therapy, Cervical cancer, Head and neck squamous-cell carcinoma (HNSCC), Non-small cell lung cancer (NSCLC), Autologous Adoptive Cell Therapy, Cellular Immunotherapy, Immuno-oncology, Tumor Infiltrating Lymphocytes, TIL, T-cell therapy, IL-2, pembrolizumab, Checkpoint inhibitor (CPI), PD-1 pathway inhibitors
Eligibility Criteria
Key Inclusion Criteria:
- Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
- Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
- Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
- Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
- Medically suitable for surgical resection of tumor tissue
- Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow and organ function
Key Exclusion Criteria:
- History of another primary malignancy within the previous 3 years
- Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
- Previously received an allogeneic stem cell transplant or organ allograft
- Previously received TIL or engineered cell therapy (eg, CAR T-cell)
- Significant cardiac disease
- Stroke or transient ischemic attack within 12 months of enrollment
- History of significant central nervous system (CNS) disorder
- Symptomatic and/or untreated CNS metastases
- History of significant autoimmune disease within 2 years prior to enrollment
- Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, IL-2, of CPI
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Participants with cervical cancer whose disease has progressed during or after treatment with platinum-based chemotherapy. Participants with combined positive score ≥ 1 should also have disease that has progressed during or after treatment with CPI.
Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI.
Participants with non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have disease which has progressed on targeted therapy and platinum-based chemotherapy.
Outcomes
Primary Outcome Measures
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Secondary Outcome Measures
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 investigator review.
Duration of response
For participants who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
Progression-free Survival
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.
Overall Survival
Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05393635
Brief Title
ITIL-168 in Advanced Solid Tumors
Acronym
DELTA-2
Official Title
A Phase 1, Open-Label, Multicenter Study Evaluating the Safety, Feasibility, and Preliminary Efficacy of ITIL-168 With Pembrolizumab in Subjects With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
business decision
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instil Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
DELTA-2 is a phase 1 clinical trial to evaluate the safety, feasibility, and preliminary efficacy of ITIL-168 with pembrolizumab in participants with advanced cancer whose disease has progressed after standard therapy. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Keywords
ITIl-168, Cell Therapy, Cervical cancer, Head and neck squamous-cell carcinoma (HNSCC), Non-small cell lung cancer (NSCLC), Autologous Adoptive Cell Therapy, Cellular Immunotherapy, Immuno-oncology, Tumor Infiltrating Lymphocytes, TIL, T-cell therapy, IL-2, pembrolizumab, Checkpoint inhibitor (CPI), PD-1 pathway inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants with cervical cancer whose disease has progressed during or after treatment with platinum-based chemotherapy. Participants with combined positive score ≥ 1 should also have disease that has progressed during or after treatment with CPI.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Participants with non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have disease which has progressed on targeted therapy and platinum-based chemotherapy.
Intervention Type
Biological
Intervention Name(s)
ITIL-168
Intervention Description
ITIL-168 is a cell therapy product derived from a participant's own TILs. A portion of tumor is resected to make a personalized ITIL-168 product. If appropriate, participants may receive bridging therapy after recovering from the tumor resection during ITIL-168 manufacturing. Once ITIL-168 has been made, the participant is treated with up to 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.
Drug: Pembrolizumab Participants will receive 1 dose of pembrolizumab following tumor resection prior to receiving ITIL-168, and additional doses for up to a year after ITIL-168 infusion.
Primary Outcome Measure Information:
Title
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Objective response rate
Description
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 investigator review.
Time Frame
Up to 60 months
Title
Duration of response
Description
For participants who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
Time Frame
Up to 60 months
Title
Progression-free Survival
Description
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.
Time Frame
Up to 60 months
Title
Overall Survival
Description
Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.
Time Frame
Up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
Medically suitable for surgical resection of tumor tissue
Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow and organ function
Key Exclusion Criteria:
History of another primary malignancy within the previous 3 years
Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
Previously received an allogeneic stem cell transplant or organ allograft
Previously received TIL or engineered cell therapy (eg, CAR T-cell)
Significant cardiac disease
Stroke or transient ischemic attack within 12 months of enrollment
History of significant central nervous system (CNS) disorder
Symptomatic and/or untreated CNS metastases
History of significant autoimmune disease within 2 years prior to enrollment
Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, IL-2, of CPI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Instil Study Director
Organizational Affiliation
Instil Bio, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ITIL-168 in Advanced Solid Tumors
We'll reach out to this number within 24 hrs