ITIL-168 in Advanced Melanoma

NCT05050006 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: ITIL-168-1012020-003862-37
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 22

Brief Summary

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

Conditions

Advanced Cutaneous Melanoma

Keywords

ITIL-168; Cell Therapy; melanoma; Autologous cell therapy; Cellular Immunotherapy; TIL; Autologous Adoptive Cell Transfer; Immuno-oncology; IL-2; Autologous Adoptive Cell Therapy; Tumor Infiltrating Lymphocytes; T-cell therapy

Outcome Measures

Primary Outcomes (1)

• 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 central review.

  Up to 60 months

Secondary Outcomes (8)

• Duration of Response

  Up to 60 months

• Progression-free Survival

  Up to 60 months

• Overall Survival

  Up to 60 months

• ORR as determined by investigators

  Up to 60 months

• Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest

  Up to 60 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.

Biological: ITIL-168

Cohort 2

EXPERIMENTAL

Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.

Biological: ITIL-168

Cohort 3

EXPERIMENTAL

Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy.

Biological: ITIL-168

Interventions

ITIL-168 BIOLOGICAL

ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 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.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
• Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
• Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
• Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
• 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

You may not qualify if:

• History of another primary malignancy within the previous 3 years
• Melanoma of uveal, acral, or mucosal origin
• 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, or IL-2.

Sponsors & Collaborators

• Instil Bio: lead

Study Sites (22)

University of California San Diego, Moores Cancer Center

La Jolla, California, 92093, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

USC - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCLA Health - Westwood Cancer Care

Los Angeles, California, 90095, United States

Location

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

University of Colorado - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

The University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Rush University Cancer Center

Chicago, Illinois, 60612, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Cleveland Clinic - Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, England, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Instil Study Director

  Instil Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants are assigned to be treated with a single dose of ITIL-168

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: October 7, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); GB (1); CA (1)