Ovarian Cancer Clinical Trial

ITIL-306 in Advanced Solid Tumors

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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
History of significant autoimmune disease within 2 years prior to enrollment
Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), human serum albumin (HAS), phosphate buffer or gentamycin

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

51

Study ID:

NCT05397093

Recruitment Status:

Recruiting

Sponsor:

Instil Bio

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There are 2 Locations for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Katalin Kenney
Contact
314-273-5118
[email protected]
Jeffrey Ward, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Justina Morgan, MPH
Contact
212-639-2000
[email protected]
Adam Schoenfeld, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

51

Study ID:

NCT05397093

Recruitment Status:

Recruiting

Sponsor:


Instil Bio

How clear is this clinincal trial information?

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