Status:
ACTIVE_NOT_RECRUITING
ITIL-306 in Advanced Solid Tumors
Lead Sponsor:
Instil Bio
Conditions:
Epithelial Ovarian Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 standar...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2039
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05397093
Start Date
August 24 2022
End Date
November 1 2039
Last Update
March 5 2024
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065