A Study of DeTIL-0255 in Adults With Advanced Malignancies

Sponsor

Nurix Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05107739

Collaborator

(none)

Enrollment

Locations

Arms

54.3

Anticipated Duration (Months)

16.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Platinum-resistant Ovarian Cancer Endometrial Cancer Cervical Cancer	Biological: Drug Product De-TIL-0255	Phase 1

Detailed Description

This study includes a safety run in and a cohort expansion. The safety run in will include patients with any of the indications under study including:

Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma Recurrent, metastatic, or persistent cervical carcinoma Advanced or recurrent endometrial cancer

Cohort expansion will include patients with advanced malignancies who have received at least two prior systemic therapies in the same indications.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Safety and Tolerability Study of DeTIL-0255 in Adults With Advanced Malignancies

Actual Study Start Date :

Dec 22, 2021

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Safety Run In Patients with gynecological malignancies	Biological: Drug Product De-TIL-0255 Autologous tumor-infiltrating lymphocytes
Experimental: EOC Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma	Biological: Drug Product De-TIL-0255 Autologous tumor-infiltrating lymphocytes
Experimental: Cervical Recurrent, metastatic, or persistent cervical carcinoma	Biological: Drug Product De-TIL-0255 Autologous tumor-infiltrating lymphocytes
Experimental: Endometrial Advanced or recurrent endometrial cancer	Biological: Drug Product De-TIL-0255 Autologous tumor-infiltrating lymphocytes

Outcome Measures

Primary Outcome Measures

Incidence of treatment emergent adverse events [24 Months]
NX-DeTIL-0255-201
Incidence of all deaths [24 Months]
NX-DeTIL-0255-201
Incidence of dose limiting toxicities [24 Months]
NX-DeTIL-0255-201
Objective response rate (ORR) per disease-specific response criteria as assessed by the Investigator [24 Months]
NX-DeTIL-0255-201
Duration of response (DOR) as assessed by the Investigator [24 Months]
NX-DeTIL-0255-201
Disease control rate (DCR) as assessed by the Investigator [24 Months]
NX-DeTIL-0255-201
Progression-free survival (PFS) as assessed by the Investigator [24 Months]
NX-DeTIL-0255-201
Overall survival (OS) as assessed by the Investigator [24 Months]
NX-DeTIL-0255-201

Secondary Outcome Measures

Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion [24 Months]
NX-DeTIL-0255-201

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
2	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14203
3	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212