A Study of DeTIL-0255 in Adults With Advanced Malignancies

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05107739
• Other study ID #: NX-DeTIL-0255-201
• Status: Terminated
• Phase: Phase 1
• Start date: December 22, 2021
• Est. completion date: May 9, 2023

Study information

• Verified date: May 2024
• Source: Nurix Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Platinum-resistant Ovarian Cancer

Intervention

Biological:
• Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Nurix Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	NX-DeTIL-0255-201	24 Months
Primary	Incidence of all deaths	NX-DeTIL-0255-201	24 Months
Primary	Incidence of dose limiting toxicities	NX-DeTIL-0255-201	24 Months
Primary	Objective response rate (ORR) per disease-specific response criteria as assessed by the Investigator	NX-DeTIL-0255-201	24 Months
Primary	Duration of response (DOR) as assessed by the Investigator	NX-DeTIL-0255-201	24 Months
Primary	Disease control rate (DCR) as assessed by the Investigator	NX-DeTIL-0255-201	24 Months
Primary	Progression-free survival (PFS) as assessed by the Investigator	NX-DeTIL-0255-201	24 Months
Primary	Overall survival (OS) as assessed by the Investigator	NX-DeTIL-0255-201	24 Months
Secondary	Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion	NX-DeTIL-0255-201	24 Months