A Study of DeTIL-0255 in Adults With Advanced Malignancies
About the study
This is a first-in-human Phase 1 multicenter, open-label oncology study designed to evaluate the safety and efficacy of NX-DeTIL-0255-201 in patients with advanced malignancies.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- One of the following malignancies: Recurrent or persistent platinum-resistant EOC, recurrent, metastatic or persistent carcinoma of the cervix with progression after treatment with taxane-containing regimen, or advance or recurrent endometrial cancer with disease progression after or during second line or greater therapy
- Disease that is metastatic and measurable by RECIST v1.1 criteria
- A resectable lesion for TIL generation
- At least 2 prior lines of therapy
- ≥ 18 years and ≤ 70 years of age
- Life expectancy of at least 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function, in the absence of growth factors
- Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol
- A signed consent form indicating that the subjects understands the purpose and procedures required for the study
EXCLUSION CRITERIA
Exclusion Criteria:
- Known untreated brain metastases
- Uncontrolled intercurrent illness
- History of known seizure disorder
- Unable to comply with study requirements
- Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
- Pregnant, breastfeeding, or planning to become pregnant while enrolled on this study or within 6 months after DeTIL infusion
- Live vaccine within 28 days of first dose of NMA chemotherapy or planned live vaccination within 6 months following DeTIL infusion
- Active known second malignancy with the exception of any of the following: Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or adequately treated follicular or papillary thyroid cancer; or any other cancer from which the patient has been disease-free for ≥ 2 years
- Systemic anti-cancer therapy, including investigational agents, or radiotherapy within 4 weeks of tumor resection
- Major surgery within 4 weeks before tumor resection, or will not have fully recovered from surgery, or has surgery planned within 8 weeks after infusion
- Use of systemic corticosteroids within 15 days (or other immunosuppressive drugs within 30 days) prior to tumor resection
- Use of biotin or other supplements containing higher that the daily adequate intake of biotin
- Clinically significant, uncontrolled cardiac, class III or IV heart failure, thromboembolic events, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug
- History or current evidence of anything that might confound the results of the study
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Platinum-resistant Ovarian Cancer,Endometrial Cancer,Cervical Cancer
Age (in years)
18 - 70
Phase
Phase 1
Participants needed
50
Est. Completion Date
Jul 31, 2026
Treatment type
Interventional
Sponsor
Nurix Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT05107739
Study number
NX-DeTIL-0255-201
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?