Status:
WITHDRAWN
ITIL-168 in Advanced Solid Tumors
Lead Sponsor:
Instil Bio
Conditions:
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05393635
Start Date
August 1 2022
End Date
December 8 2022
Last Update
December 20 2022
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