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CAR T-cell Therapy
DeTIL-0255 for Advanced Cancers
Phase 1
Waitlist Available
Research Sponsored by Nurix Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
≥ 18 years and ≤ 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
Adults aged 18-70 with advanced cancers like ovarian, cervical, or endometrial cancer that have spread and are measurable. They must have tried at least two other treatments, be in fairly good health (ECOG 0 or 1), not pregnant or breastfeeding, able to use contraception, and have a life expectancy of over four months.Check my eligibility
What is being tested?
The trial is testing DeTIL-0255, a new drug for adults with certain advanced cancers. It's an early-stage study to see if the drug is safe and works well. Participants will receive this experimental treatment after meeting specific health criteria.See study design
What are the potential side effects?
Since it's a first-in-human study of DeTIL-0255, exact side effects aren't listed but may include typical reactions to cancer drugs such as fatigue, nausea, immune-related issues and potential infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of: advanced ovarian, cervical, or endometrial, and has not responded well to previous treatments.
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I am between 18 and 70 years old.
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My cancer has spread and can be measured for treatment response.
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My organs and bone marrow are working well without any medical help.
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I have undergone at least 2 different treatments for my condition.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be surgically removed to generate TILs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR) as assessed by the Investigator
Duration of response (DOR) as assessed by the Investigator
Incidence of all deaths
+5 moreSecondary outcome measures
Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion
Trial Design
4Treatment groups
Experimental Treatment
Group I: Safety Run InExperimental Treatment1 Intervention
Patients with gynecological malignancies
Group II: EndometrialExperimental Treatment1 Intervention
Advanced or recurrent endometrial cancer
Group III: EOCExperimental Treatment1 Intervention
Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma
Group IV: CervicalExperimental Treatment1 Intervention
Recurrent, metastatic, or persistent cervical carcinoma
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Who is running the clinical trial?
Nurix Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
797 Total Patients Enrolled
Paula O'ConnorStudy DirectorNurix Therapeutics, Inc.
Robert BrownStudy DirectorNurix Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery 4 weeks before or won't have one 8 weeks after treatment.I haven't had cancer treatment or radiotherapy in the last 4 weeks before my tumor surgery.My cancer is one of: advanced ovarian, cervical, or endometrial, and has not responded well to previous treatments.I have a known history of seizures.I am between 18 and 70 years old.I haven't taken steroids or immunosuppressants in the last 15 (or 30) days.I haven't had a live vaccine within the last 28 days and won't plan one for 6 months after DeTIL infusion.I do not take biotin or supplements with high biotin levels.My cancer has spread and can be measured for treatment response.My organs and bone marrow are working well without any medical help.I have undergone at least 2 different treatments for my condition.I have another cancer but it's either skin, thyroid, or I've been cancer-free for 2 years.I have brain metastases that have not been treated.I am fully active or restricted in physically strenuous activity but can do light work.I do not have severe heart problems or recent heart attacks.My cancer can be surgically removed to generate TILs.I do not have any unmanaged ongoing illnesses.Side effects from my past cancer treatments have mostly gone away.
Research Study Groups:
This trial has the following groups:- Group 1: Cervical
- Group 2: EOC
- Group 3: Safety Run In
- Group 4: Endometrial
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any risk inherent in utilizing Drug Product De-TIL-0255?
"Due to the early phase nature of this drug trial (Phase 1), Drug Product De-TIL-0255 has been assigned a safety rating of one by our team at Power. This is based on limited evidence regarding its efficacy and safety profile."
Answered by AI
Is the age range for this medical experiment inclusive of individuals aged 35 and up?
"The age range for potential participants in this trial is 18 to 70 years old."
Answered by AI
What are the parameters for participation in this clinical trial?
"In order to be accepted for this clinical trial, the patient must have a diagnosis of platinum-resistant ovarian cancer (proc) and fall between 18 and 70 years old. The researchers are seeking 50 participants in total."
Answered by AI
Are there still openings available for participants in this research?
"As indicated on clinicaltrials.gov, this medical trial is no longer actively recruiting participants. Initially posted on December 22nd 2021 and last edited in November 15th 2022, the study has since concluded; however, there are 536 other studies seeking individuals at present."
Answered by AI
How many locations are undertaking this experiment?
"This research initiative is being conducted from UPMC, Moffitt Cancer Center & Research Institute, and Roswell Park Comprehensive Cancer Center joined by an additional 5 sites. All are located in differing states with Tampa, Florida; Buffalo, New york; and New Brunswick, New jersey respectively hosting the first 3."
Answered by AI
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