ITIL-306 in Advanced Solid Tumors

NCT05397093 | Terminated Phase 1 FDA Drug

• 1 other identifier: ITIL-306-201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

ITIL-306-201 is a phase 1a/1b, multicenter, clinical trial evaluating the safety and feasibility of ITIL-306 in adult participants with advanced solid tumors whose disease has progressed after standard therapy. ITIL-306 is a cell therapy derived from a participant's own tumor-infiltrating immune cells (lymphocytes; TILs) and contains a unique molecule designed to increase TIL activity when it encounters folate receptor α (FOLR1) on the tumor.

Conditions

Epithelial Ovarian Cancer; Non-small Cell Lung Cancer; Renal Cell Carcinoma

Keywords

ITIL-306; Cell Therapy; Epithelial ovarian cancer (EOC); Non-small cell lung cancer (NSCLC); Renal cell carcinoma (RCC); Fallopian tube carcinoma; Tumor Infiltrating Lymphocytes; TIL; T-cell therapy; Folate receptor α (FOLR1); Anti-folate receptor α (FOLR1); Autologous Adoptive Cell Therapy; Checkpoint, PD-1 axis inhibitor; Peritoneal carcinoma; Cellular Immunotherapy; Immuno-oncology; Costimulatory antigen receptor (CoStAR)

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)

  Up to 24 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to 60 months

• Duration of response (DOR)

  Up to 60 months

• Progression-free survival (PFS)

  Up to 60 months

• Overall Survival (OS)

  Up to 60 months

Study Arms (2)

Phase 1a: Dose Escalation

EXPERIMENTAL

Various doses will be tested in participants with EOC, NSCLC and RCC.

Biological: ITIL-306

Phase 1b: Expansion

EXPERIMENTAL

Cohort 1: Participants with epithelial ovarian cancer (EOC) Cohort 2: Participants with non-small cell lung cancer (NSCLC) Cohort 3: Participants with renal cell carcinoma (RCC)

Biological: ITIL-306

Interventions

ITIL-306 BIOLOGICAL

ITIL-306 is a cell therapy product derived from a participant's own TILs and contains a unique molecule designed to increase TIL activity when it encounters FOLR1 on the tumor. A portion of the participant's tumor is surgically removed to make a personalized ITIL-306 product. Once ITIL-306 has been made, the participant is treated with 3 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by 2 days of rest then a single infusion of ITIL-306.

Phase 1a: Dose Escalation; Phase 1b: Expansion

Eligibility Criteria

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

You may qualify if:

• Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort.
• Phase 1a Dose Escalation: High-grade serous epithelial carcinoma of the ovary, fallopian tube, or peritoneum, adenocarcinoma of the lung, or clear-cell renal cell carcinoma.
• Phase 1b Expansion:
• Cohort 1: High grade serous, endometrioid, or clear cell epithelial carcinoma of the ovary, fallopian tube, or peritoneum.
• Cohort 2: Squamous-cell carcinoma or adenocarcinoma of the lung.
• Cohort 3: Clear cell or papillary RCC.
• Disease must have unequivocally progressed during or after at least 1 prior line of systemic therapy that must include the following parameters (by indication):
• Phase 1a dose escalation and Phase 1b Cohort 1: Participants with EOC whose disease has progressed during or after 1 prior line (at least 4 cycles) of platinum-based chemotherapy and had disease progression within 6 months from the last dose of the platinum agent. Participants who received 2 or more lines of platinum therapy must have disease which has progressed on or within 6 months after the date of the last dose of the platinum agent. Participants with BRCA-mutated EOC must have received previous PARP inhibitor therapy.
• Phase 1a dose escalation and Phase 1b Cohort 2: Participants with NSCLC whose disease has progressed after 1 prior line of platinum-based doublet chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK/KRAS) are required to have progressed on targeted therapy in addition to a platinum-based doublet chemotherapy
• Phase 1a dose escalation and Phase 1b Cohort 3: Participants with RCC whose disease has progressed after 1 prior line of antiangiogenic therapy and a PD-1-axis inhibitor.
• 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
• Phase 1a:
• EOC of the following subtypes: low-grade, endometrioid, clear cell, mucinous, sarcomatous, or mixed.
• NSCLC of the following subtypes: squamous, neuroendocrine differentiation.
• RCC of the following subtypes: nonclear-cell RCC
• Phase 1b:
• Cohort 1: Participants with mucinous, sarcomatous, and low-grade EOC.
• Cohort 2: Participants with small cell lung cancer, or NSCLC with neuroendocrine differentiation
• Cohort 3: Participants with nonclear-cell RCC, except papillary RCC
• 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

Sponsors & Collaborators

• Instil Bio: lead

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Fallopian Tube Diseases

Study Officials

• Instil Study Director

  Instil Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: August 24, 2022
• Primary Completion: October 10, 2023
• Study Completion: March 6, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)