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ITIL-306

Phase 1

Epithelial Ovarian Cancer | Monoclonal antibody | Oncology |Instil Bio, Inc.|Last Updated: Apr 15, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded
Trial Stopped -NCT05397093: The study was terminated early due to discontinuation of development of the investigational program

Clinical trial landscape

ITIL-306 · 1 trial · 3 indications

Phase 1 1
NCT05397093ITIL-306 in Advanced Solid TumorsEpithelial Ovarian Cancer
TERMINATED1 Analytics
PHASE1TERMINATED
ITIL-306 in Advanced Solid Tumors
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)
Up to 24 months

Secondary Endpoints

Objective response rate (ORR)
Up to 60 months
Duration of response (DOR)
Up to 60 months
Progression-free survival (PFS)
Up to 60 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a: Dose EscalationEXPERIMENTALVarious doses will be tested in participants with EOC, NSCLC and RCC.
Phase 1b: ExpansionEXPERIMENTALCohort 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)

Interventions

NameTypeDescription
ITIL-306BIOLOGICALITIL-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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 ca...

Countries:United States
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Frequently asked questions about ITIL-306

What is ITIL-306 used for?

ITIL-306 is an investigational monoclonal antibody being developed for the treatment of epithelial ovarian cancer. It is also being studied in other advanced solid tumors, including non-small cell lung cancer and renal cell carcinoma. The drug is currently in Phase 1 clinical development.

What does ITIL-306 target?

ITIL-306 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat epithelial ovarian cancer and other advanced solid tumors. Its mechanism of action is not publicly detailed.

Who makes ITIL-306?

ITIL-306 is being developed by Instil Bio, Inc., a biopharmaceutical company. Instil Bio is publicly traded on the Nasdaq under the ticker symbol TIL. The company is conducting clinical trials to evaluate the safety and efficacy of ITIL-306 in patients with advanced solid tumors.

What phase is ITIL-306 in?

ITIL-306 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of ITIL-306 in patients with advanced solid tumors.

What clinical trials is ITIL-306 in?

ITIL-306 is being evaluated in a Phase 1 clinical trial with the identifier NCT05397093, titled 'ITIL-306 in Advanced Solid Tumors.' The trial is enrolling patients with epithelial ovarian cancer, non-small cell lung cancer, and renal cell carcinoma. The study is being conducted in the United States.

Is ITIL-306 the same as any other drug?

ITIL-306 is a distinct investigational drug developed by Instil Bio. No alternative names for ITIL-306 have been reported. It is a monoclonal antibody being studied for the treatment of advanced solid tumors, including epithelial ovarian cancer.