NCT05397093 is a Phase 1 clinical trial of ITIL-306 in Epithelial Ovarian Cancer, sponsored by Instil Bio.

Who is sponsoring NCT05397093?

NCT05397093 is sponsored by Instil Bio.

What drugs are being tested in NCT05397093?

Interventions in NCT05397093: ITIL-306.

What condition does NCT05397093 study?

NCT05397093 studies Epithelial Ovarian Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma.

Is NCT05397093 still recruiting?

NCT05397093 is currently terminated. Last updated 15 April 2026.

Last reviewed 2026-04-15 · How we verify

NCT05397093

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ITIL-306 in Advanced Solid Tumors

Terminated Phase 1 Last updated 15 April 2026

What this trial tests

Phase 1 trial testing ITIL-306 in Epithelial Ovarian Cancer in 1 participant. Terminated before completion.

Timeline

24 August 2022

Primary endpoint
10 October 2023

6 March 2026

Quick facts

Lead sponsor	Instil Bio
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	24 August 2022
Primary completion	10 October 2023
Estimated completion	6 March 2026
Sites	2 locations across United States

Drugs / interventions tested

ITIL-306 — full drug profile →

Conditions studied

Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →

Sponsor

Instil Bio — full company profile →

Who can join

18 and older, any sex, with Epithelial Ovarian Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor-Infiltrating Lymphocyte Therapy in Melanoma: Facts to the Future.
Betof Warner A, Corrie PG, Hamid O. · · 2023 · cited 81× · PMID 36485001 · DOI 10.1158/1078-0432.ccr-22-1922
Folate Receptor Alpha-A Novel Approach to Cancer Therapy.
Gonzalez T, Muminovic M, Nano O, Vulfovich M. · · 2024 · cited 52× · PMID 38256120 · DOI 10.3390/ijms25021046
Developments in targeted therapy & immunotherapy-how non-small cell lung cancer management will change in the next decade: a narrative review.
Li MSC, Mok KKS, Mok TSK. · · 2023 · cited 37× · PMID 37675321 · DOI 10.21037/atm-22-4444
Cellular Therapy for Lung Cancer: Focusing on Chimeric Antigen Receptor T (CAR T) Cells and Tumor-Infiltrating Lymphocyte (TIL) Therapy.
Katiyar V, Chesney J, Kloecker G. · · 2023 · cited 19× · PMID 37509394 · DOI 10.3390/cancers15143733
CAR Based Immunotherapy of Solid Tumours-A Clinically Based Review of Target Antigens.
Maher J, Davies DM. · · 2023 · cited 13× · PMID 36829563 · DOI 10.3390/biology12020287
TIL Therapy in Lung Cancer: Current Progress and Perspectives.
Hu W, Bian Y, Ji H. · · 2024 · cited 11× · PMID 39422665 · DOI 10.1002/advs.202409356
Therapeutic potential of tumor-infiltrating lymphocytes in non-small cell lung cancer.
Plaugher DR, Childress AR, Gosser CM, Esoe DP, et al · · 2024 · cited 11× · PMID 39369769 · DOI 10.1016/j.canlet.2024.217281
Nanotechnology for boosting ovarian cancer immunotherapy.
Kaur P, Singh SK, Mishra MK, Singh S, et al · · 2024 · cited 7× · PMID 39402681 · DOI 10.1186/s13048-024-01507-z

Verify or expand the search:

Other recruiting trials for Epithelial Ovarian Cancer

Currently open trials in the same condition.

NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07480954 — Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) · Phase 1, PHASE2 · recruiting
NCT07218809 — AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Can · Phase 3 · recruiting
NCT07495397 — Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targete · NA · recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting

Other Instil Bio trials

Trials by the same sponsor.

NCT05050006 — ITIL-168 in Advanced Melanoma · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05397093 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Instil Bio
Last refreshed: 15 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05397093.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing