A Study of DeTIL-0255 in Adults With Advanced Malignancies

NCT05107739 | Terminated Phase 1 FDA Drug

• 1 other identifier: NX-DeTIL-0255-201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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.

Conditions

Platinum-resistant Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Keywords

NX-DeTIL-0255; Adoptive Cell Therapy; Tumor Infiltrating Lymphocyte; ACT; TIL; DeTIL

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion

  24 Months

Study Arms (4)

Safety Run In

EXPERIMENTAL

Patients with gynecological malignancies

Biological: Drug Product De-TIL-0255

EOC

EXPERIMENTAL

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

Biological: Drug Product De-TIL-0255

Cervical

EXPERIMENTAL

Recurrent, metastatic, or persistent cervical carcinoma

Biological: Drug Product De-TIL-0255

Endometrial

EXPERIMENTAL

Advanced or recurrent endometrial cancer

Biological: Drug Product De-TIL-0255

Interventions

Drug Product De-TIL-0255 BIOLOGICAL

Autologous tumor-infiltrating lymphocytes

Cervical; EOC; Endometrial; Safety Run In

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (4)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• Paula O'Connor

  Nurix Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 4, 2021
• Study Start: December 22, 2021
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)