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A Study of DeTIL-0255 in Adults With Advanced Malignancies | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT05107739•Nurix Therapeutics, Inc.

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.

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

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
+4 more criteria

Locations (4)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

December 22, 2021

Primary Completion Date

May 9, 2023

Completion Date

May 9, 2023

Last Updated

May 3, 2024

Enrollment

ACTUAL participants

Conditions

Platinum-resistant Ovarian CancerEndometrial CancerCervical Cancer

Interventions

Drug Product De-TIL-0255

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of DeTIL-0255 in Adults With Advanced Malignancies

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform