ITIL-168 in Advanced Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05393635
• Other study ID #: ITIL-168-102
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2022
• Source: Instil Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Cervical Cancer
• Head and Neck Squamous Cell Carcinoma
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Uterine Cervical Neoplasms

Intervention

Biological:
• ITIL-168
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instil Bio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest		Up to 24 months
Secondary	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.	Up to 60 months
Secondary	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.	Up to 60 months
Secondary	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.	Up to 60 months
Secondary	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