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Platinum-resistant Ovarian CancerPhase 1NCT05107739

A Study of DeTIL-0255 in Adults With Advanced Malignancies

A Phase 1 study testing Drug Product De-TIL-0255 in people with Platinum-resistant Ovarian Cancer and Endometrial Cancer, run by Nurix Therapeutics, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Drug Product De-TIL-0255
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
4 sitesUnited States
Study dates
22 Dec 2021to 9 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Drug Product De-TIL-0255
Keywords
NX-DeTIL-0255, Adoptive Cell Therapy, Tumor Infiltrating Lymphocyte, ACT, TIL, DeTIL
Medical subject headings
Endometrial Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug Product De-TIL-0255Biological

    Autologous tumor-infiltrating lymphocytes

Study groups in NCT05107739
Study groupRoleWhat they receive
Safety Run InExperimentalPatients with gynecological malignancies
Receives: Biological: Drug Product De-TIL-0255
EOCExperimentalRecurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma
Receives: Biological: Drug Product De-TIL-0255
CervicalExperimentalRecurrent, metastatic, or persistent cervical carcinoma
Receives: Biological: Drug Product De-TIL-0255
EndometrialExperimentalAdvanced or recurrent endometrial cancer
Receives: Biological: Drug Product De-TIL-0255

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent adverse events

    NX-DeTIL-0255-201

    Measured: 24 Months

  2. Incidence of all deaths

    NX-DeTIL-0255-201

    Measured: 24 Months

  3. Incidence of dose limiting toxicities

    NX-DeTIL-0255-201

    Measured: 24 Months

  4. Objective response rate (ORR) per disease-specific response criteria as assessed by the Investigator

    NX-DeTIL-0255-201

    Measured: 24 Months

  5. Duration of response (DOR) as assessed by the Investigator

    NX-DeTIL-0255-201

    Measured: 24 Months

  6. Disease control rate (DCR) as assessed by the Investigator

    NX-DeTIL-0255-201

    Measured: 24 Months

  7. Progression-free survival (PFS) as assessed by the Investigator

    NX-DeTIL-0255-201

    Measured: 24 Months

  8. Overall survival (OS) as assessed by the Investigator

    NX-DeTIL-0255-201

    Measured: 24 Months

Secondary outcomes (1)

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

    NX-DeTIL-0255-201

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2021
  2. Study start22 Dec 2021
  3. Primary completion9 May 2023
  4. Study completion9 May 2023

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05107739
Sponsor's protocol ID
NX-DeTIL-0255-201
Status last verified
May 2024
First submitted
4 Oct 2021
Last updated
3 May 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug Product De-TIL-0255 in people with Platinum-resistant Ovarian Cancer and Endometrial Cancer, run by Nurix Therapeutics, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (time frame: 24 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05107739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

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