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ITIL-168 in Advanced Solid Tumors (DELTA-2)

I

Instil Bio

Status and phase

Withdrawn
Phase 1

Conditions

Non-small Cell Lung Cancer
Cervical Cancer
Head and Neck Squamous Cell Carcinoma

Treatments

Biological: ITIL-168

Study type

Interventional

Funder types

Industry

Identifiers

NCT05393635
ITIL-168-102

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Cohort 1
Experimental group
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.
Treatment:
Biological: ITIL-168
Cohort 2
Experimental group
Description:
Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI.
Treatment:
Biological: ITIL-168
Cohort 3
Experimental group
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.
Treatment:
Biological: ITIL-168

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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