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Locally Advanced Cervical CarcinomaPhase 1NCT06626256

STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma

A Phase 1 study testing Aldesleukin, Biopsy and Biospecimen Collection in people with Locally Advanced Cervical Carcinoma and Locally Advanced Colorectal Carcinoma, run by City of Hope Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aldesleukin, Biopsy and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
5 Dec 2025to 30 Oct 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative.
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agree to research biopsies while on-study
  • Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed
  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
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  • Anticipated life expectancy of > 6 months at the time of enrollment
  • Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CC), renal cell carcinoma (RCC), cervical cancer (CC) and melanoma, meeting the following criteria will be eligible:
  • Cytologically or histologically confirmed locally advanced, unresectable, or metastatic PDAC, CRC, RCC, CC, melanoma
  • Patients must have received at least 1 line of standard therapy prior to receiving STIL101 for injection. Note: Patients may be enrolled prior to starting treatment to harvest tumor and blood samples for tumor infiltrating lymphocyte (TIL) generation
  • For pancreatic cancer patients:
  • Patients on first line treatment will need to receive at least 4 months of standard chemotherapy before receiving STIL101 for injection
  • In the second line setting, these patients may opt to receive STIL101 for injection at any time
  • For melanoma cancer patients: Patients need to have received prior PD1 therapy and BRAF inhibitor treatment in patients with a V600E mutation
  • For RCC, CRC, CC patients: Patients need to have failed at least 1 line of prior therapy
  • Measurable disease by RECIST 1.1
  • At least one lesion (or aggregate of lesions resected) that can be safety biopsied (excisional) and yield a volume (target of > 1cm^3) to generate STIL101 for injection (principal investigator [PI] discretion)
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • NOTE: Growth factor is not permitted within 14 days of screening ANC assessment
  • Platelets ≥ 100,000/mm^3
  • NOTE: Platelet transfusions are not permitted within 14 days of screening platelet assessment
  • Hemoglobin ≥ 8 g/dL
  • NOTE: Red blood cell transfusions are not permitted within 14 days of screening platelet assessment
  • Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless participant has Gilbert's disease which allows total bilirubin ≤ 3 x ULN)
  • Aspartate aminotransferase (AST) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
  • Alanine transaminase (ALT) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
  • Creatinine clearance (CRCl) of ≥ 40 mL/min per 24-hour urine test or the Cockcroft-Gault formula
  • Oxygen (O2) saturation > 92% on room air not requiring oxygen supplementation
  • Note: To be performed within 28 days prior to start of protocol therapy
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Note: To be performed within 8 weeks prior to start of protocol therapy
  • If not receiving anticoagulants: International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
  • If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
  • Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR)
  • If seropositive for HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetected
  • QuantiFERON-TB Gold or equivalent
  • Results do not impact patient eligibility; however, the test must be initiated prior to enrollment
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Prior organ transplant
  • Concomitant herbal medications with exception to cannabidiol (CBD), which is allowed
  • Continuous systemic steroid therapy (i.e., > 10 mg/day of prednisone or other steroid equivalent dose) or other immunosuppressive therapies. Physical replacement doses (i.e., adrenocortical insufficiency), inhaled or topical steroids at ≤ 10 mg/day of prednisone or another steroid equivalent dose are permissible in the absence of active auto-immune disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents, including history of hypersensitivity to any drugs of the aminoglycoside group
  • Prior or current known uveitis within 6 months of informed consent
  • Active viral, bacterial, or fungal infection requiring treatment. Patients must be seronegative for the human immunodeficiency virus (HIV) and syphilis (RPR). Patients with hepatitis infections are allowed with undetected viral load
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  • Primary immunodeficiency (such as severe combined immunodeficiency [SCID] or acquired immunodeficiency syndrome [AIDS])
  • End-stage renal disorder requiring hemodialysis
  • Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification
  • Known clinically significant pulmonary conditions within 6 months of informed consent
  • Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, nonmelanoma skin cancer and low grade (Gleason score ≤ 6=Gleason group 1) localized prostate cancer. Prior malignancies not listed require PI approval
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

About this study

Official title: A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, and Melanoma

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). STIL101 for injection, an autologous (made from the patients own cells) cellular therapy, is made up of specialized white blood cells called lymphocytes or "T cells" collected from a piece of the patients tumor tissue. The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection. STIL101 for injection is then given to the patient where it may attack the tumor. Giving chemotherapy, such as cyclophosphamide and fludarabine, helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes. Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, CRC, RCC, CC and melanoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the safety of administering STIL101 for injection in subjects with locally advanced, unresectable, or metastatic pancreatic ducal adenocarcinoma (PDAC), CRC, RCC CC or melanoma.

SECONDARY OBJECTIVES:

  1. Summarize the efficacy observed due to STIL101 for injection in patients with locally advanced, unresectable or metastatic PDAC, CRC, RCC, CC or melanoma:

Ia. Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Immune-Modified (i)RECIST 1.0; Ib. Disease control rate (DCR) as measured from STIL101 infusion; Ic. Overall survival (OS) as measured from STIL101 infusion; Id. Progression-free survival (PFS) as measured from STIL101 infusion. II. Summarize pre-STIL101 for injection therapy and outcomes from first study-related procedure.

III. Evaluate the feasibility and timing of generating STIL101 for injection. IV. Describe STIL101 cell count in patients with respect to baseline characteristics, clinical outcome and adverse events.

EXPLORATORY OBJECTIVE:

  1. Biological correlatives associated with STIL101 for injection creation and infusion.

OUTLINE:

Patients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy. Patients with successful generation of STIL101 for injection receive cyclophosphamide intravenously (IV) over 2 hours on days -5 to -4, fludarabine IV over 30 minutes on days -5 to -1 and STIL101 for injection IV on day 0 in the absence of disease progression or unacceptable toxicity. Patients also receive aldesleukin subcutaneously (SC) once daily (QD) on day 0 for up to 6-10 days. Additionally, patients undergo blood sample collection, biopsy, computed tomography (CT) and optional magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at days 42, 56, 70 and 84 then every 2-4 weeks up to week 96 or progression. Patients who discontinued treatment are followed up every 6 months.

Being tested
Aldesleukin, Biopsy, Biospecimen Collection, Computed Tomography, Cyclophosphamide
Medical subject headings
Uterine Cervical Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Renal Cell, Pancreatic Neoplasms

What participants receive

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

  • AldesleukinBiological

    Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2

    Given SC

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518

    Given IV

  • Excisional BiopsyProcedure or surgery

    Also called Biopsy, Excisional, surgical biopsy

    Undergo excisional biopsy

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Standard TreatmentProcedure or surgery

    Receive standard of care therapy

  • Therapeutic Tumor Infiltrating LymphocytesBiological

    Also called Tumor Infiltrating Lymphocytes

    Given STIL101 for injection IV

Study groups in NCT06626256
Study groupRoleWhat they receive
Treatment (STIL101 for injection)ExperimentalPatients undergo excisional biopsy and continue receiving standard of care therapy for 3-4 months prior to the start of study therapy. Patients with successful generation of STIL101 for injection receive cyclophosphamide IV over 2 hours on days -5 to -4, fludarabine IV over 30 minutes on days -5 to -1 and STIL101 for injection IV on day 0 in the absence of disease progression or unacceptable toxicity. Patients also receive aldesleukin SC QD on day 0 for up to 6-10 days. Additionally, patients undergo blood sample collection, biopsy, CT and optional MRI throughout the study.
Receives: Biological: Aldesleukin; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Excisional Biopsy; Drug: Fludarabine; Procedure: Magnetic Resonance Imaging; Procedure: Standard Treatment; Biological: Therapeutic Tumor Infiltrating Lymphocytes

What is being measured

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

  1. Infusion limiting toxicities (ILTs)

    Assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. ILTs will be summarized by severity, grade and attribution.

    Measured: From the start of STIL101 for injection up to 28 days

  2. Treatment-related adverse events (AEs)

    Assessed by NCI CTCAE v 5.0. AEs will be summarized by severity, grade and attribution.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Overall response rate (ORR)

    The proportion of subjects with confirmed complete response (CR) / immune related (i)CR or partial response (PR) / iPR will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Immune-Modified (i)RECIST 1.0.

    Measured: Up to 2 years

  2. Disease control rate

    The proportion of subjects who achieve CR/iCR, PR/iPR or maintain at least stable disease will be assessed using RECIST 1.1/iRECIST 1.0.

    Measured: From start of STIL101 for injection infusion for at least one post-treatment scan up to 2 years

  3. Overall survival

    Analysis will be descriptive.

    Measured: From the start of STIL101 for injection until death due to any cause up to 2 years

  4. Overall survival

    Analysis will be descriptive.

    Measured: From excisional biopsy until death due to any cause up to 2 years

  5. Progression-free survival

    Analysis will be descriptive.

    Measured: From start of STIL101 for injection infusion until documented progressive disease or death due to any cause up to 2 years

  6. Failure to receive STIL101 after excisional biopsy

    Analysis will be descriptive.

    Measured: Up to 2 years

  7. Time to lymphodepleting chemotherapy

    Analysis will be descriptive.

    Measured: From subject informed consent to start of lymphodepleting chemotherapy up to 2 years

  8. Excisional biopsy complication rate

    Analysis will be descriptive.

    Measured: Up to 2 years

  9. STIL101 for injection generation times

    Analysis will be descriptive.

    Measured: Up to 2 years

  10. Successful STIL101 for injection generation and administration

    Success rate for generation will be summarized and causes of failure will be documented. Those unable to receive STIL101 for injection will also be summarized.

    Measured: Up to 2 years

  11. STIL101 cell count

    STIL101 cell count in patients with respect to baseline characteristics, clinical outcome and AEs will be described.

    Measured: Up to 2 years

Timeline

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

  1. First posted3 Oct 2024
  2. Study start5 Dec 2025 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Why it stopped: no resource

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06626256
Sponsor's protocol ID
24231
Other IDs
NCI-2024-08121, 24231, P30CA033572
Status last verified
Dec 2025
First submitted
2 Oct 2024
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aldesleukin, Biopsy and Biospecimen Collection in people with Locally Advanced Cervical Carcinoma and Locally Advanced Colorectal Carcinoma, run by City of Hope Medical Center.

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 41 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: withdrawn, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Infusion limiting toxicities (ILTs) (time frame: From the start of STIL101 for injection up to 28 days). The study lists 2 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 NCT06626256.

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 24 Dec 2025.

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