A Study of DeTIL-0255 in Adults With Advanced Malignancies

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; Endometrial Cancer; Platinum-resistant Ovarian Cancer
• Intervention / Treatment: Biological: Drug Product De-TIL-0255

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Comprehensive Cancer Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion	NX-DeTIL-0255-201	24 Months

Collaborators and Investigators

• Sponsor: Nurix Therapeutics, Inc.
• Investigators: Study Director: Robert Brown, Nurix Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Adoptive Cell Therapy; NX-DeTIL-0255; Tumor Infiltrating Lymphocyte; ACT; TIL; DeTIL
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: NX-DeTIL-0255-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No