Clinical trial NCT05393635: ITIL-168 in Advanced Solid Tumors
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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: 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
Lead sponsor: Instil Bio
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
timeFrame: Up to 24 months
Secondary outcomes:
measure: Objective response rate
timeFrame: Up to 60 months
measure: Duration of response
timeFrame: Up to 60 months
measure: Progression-free Survival
timeFrame: Up to 60 months
measure: Overall Survival
timeFrame: Up to 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Instil Bio, Inc.
name: Instil Study Director
role: STUDY_DIRECTOR
References: