Epithelial Ovarian CancerPhase 1NCT05397093
ITIL-306 in Advanced Solid Tumors
A Phase 1 study testing ITIL-306 in people with Epithelial Ovarian Cancer and Non-small Cell Lung Cancer, run by Instil Bio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Ovarian Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- ITIL-306
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2022to 6 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1a/1b, Open-Label, Multicenter Study Evaluating the Safety and Feasibility of ITIL-306 in Subjects With Advanced Solid Tumors
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.
- Being tested
- ITIL-306
- 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)
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITIL-306Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Various doses will be tested in participants with EOC, NSCLC and RCC. Receives: 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) Receives: Biological: ITIL-306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)
Measured: Up to 24 months
Secondary outcomes (4)
Objective response rate (ORR)
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.
Measured: Up to 60 months
Duration of response (DOR)
For participants who experience an objective response, DOR is defined as the time from their first objective response to disease progression or death.
Measured: Up to 60 months
Progression-free survival (PFS)
PFS is defined as the time from the ITIL-306 infusion date to the date of disease progression or death from any cause.
Measured: Up to 60 months
Overall Survival (OS)
OS is defined as the time from the ITIL-306 infusion date to the date of death from any cause.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start24 Aug 2022
- Primary completion10 Oct 2023
- Study completion6 Mar 2026
Why it stopped: The study was terminated early due to discontinuation of development of the investigational program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instil Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Instil Study Director, Study director, Instil Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397093
- Sponsor's protocol ID
- ITIL-306-201
- Status last verified
- Apr 2026
- First submitted
- 25 May 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Open-Label, Multicenter Study Evaluating the Safety and Feasibility of ITIL-306 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05397093
- Acronym / sponsor ID
- ITIL-306-201
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to discontinuation of development of the investigational program
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Instil BioIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Biological: ITIL-306Various doses will be tested in participants with EOC, NSCLC and RCC. |
| Phase 1b: Expansion | Experimental | Biological: ITIL-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort.
- Disease must have unequivocally progressed during or after at least 1 prior line of systemic therapy that must include the following parameters (by indication):
- 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
Key exclusion criteria (17 listed)
- History of another primary malignancy within the previous 3 years
- Phase 1a:
- Phase 1b:
- Previously received an allogeneic stem cell transplant or organ allograft
- Previously received TIL or engineered cell therapy (eg, CAR T-cell)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITIL-306ITIL-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. | Biological | Phase 1a: Dose Escalation, Phase 1b: Expansion |
Primary outcome
Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)
Time frame: Up to 24 months
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 60 months
Duration of response (DOR)
Time frame: Up to 60 months
Progression-free survival (PFS)
Time frame: Up to 60 months
Overall Survival (OS)
Time frame: Up to 60 months
Results and safety
The study was stopped early (reason given: The study was terminated early due to discontinuation of development of the investigational program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Instil Study Director study director
Instil Bio, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITIL-306 in people with Epithelial Ovarian Cancer and Non-small Cell Lung Cancer, run by Instil Bio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to discontinuation of development of the investigational program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.