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A Study of DeTIL-0255 in Adults With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05107739
Recruitment Status : Active, not recruiting
First Posted : November 4, 2021
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Nurix Therapeutics, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 22, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  2. Incidence of all deaths [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  3. Incidence of dose limiting toxicities [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  4. Objective response rate (ORR) per disease-specific response criteria as assessed by the Investigator [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  5. Duration of response (DOR) as assessed by the Investigator [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  6. Disease control rate (DCR) as assessed by the Investigator [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  7. Progression-free survival (PFS) as assessed by the Investigator [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201

  8. Overall survival (OS) as assessed by the Investigator [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201


Secondary Outcome Measures :
  1. Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion [ Time Frame: 24 Months ]
    NX-DeTIL-0255-201


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05107739


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Nurix Therapeutics, Inc.
Investigators
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Study Director: Robert Brown Nurix Therapeutics, Inc.
More Information
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Responsible Party: Nurix Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05107739    
Other Study ID Numbers: NX-DeTIL-0255-201
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nurix Therapeutics, Inc.:
NX-DeTIL-0255
Adoptive Cell Therapy
Tumor Infiltrating Lymphocyte
 ACT
TIL
DeTIL
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
 Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases