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ITIL-306 in Advanced Solid Tumors

Phase 1
Active, not recruiting
Conditions
Epithelial Ovarian Cancer
Non-small Cell Lung Cancer
Renal Cell Carcinoma
Interventions
Biological: ITIL-306
Registration Number
NCT05397093
Lead Sponsor
Instil Bio
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
51
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

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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Phase 1a: Dose EscalationITIL-306Various doses will be tested in participants with EOC, NSCLC and RCC.
Phase 1b: ExpansionITIL-306Cohort 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)
Primary Outcome Measures
NameTimeMethod
Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)Up to 24 months
Secondary Outcome Measures
NameTimeMethod
Progression-free survival (PFS)Up to 60 months

PFS is defined as the time from the ITIL-306 infusion date to the date of disease progression or death from any cause.

Objective response rate (ORR)Up to 60 months

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.

Duration of response (DOR)Up to 60 months

For participants who experience an objective response, DOR is defined as the time from their first objective response to disease progression or death.

Overall Survival (OS)Up to 60 months

OS is defined as the time from the ITIL-306 infusion date to the date of death from any cause.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

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