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Phase II study of intratumoral GETACATETIDE in patients with locally advanced or metastatic adrenocortical carcinoma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on patients with locally advanced or metastatic adrenocortical carcinoma, a rare cancer that starts in the outer layer of the adrenal gland and may have spread to nearby tissue or distant sites. The experimental medication being tested is CY-101, which contains the active substance getacatetide and is given as a solution that is injected directly into the tumor (intratumoural administration).

The purpose of the study is to identify the optimal amount of the medication and to evaluate its ability to shrink or stop the growth of the cancer (anti‑tumour activity). The research is conducted as a phase II trial, meaning it is designed to test different dose levels for safety and effectiveness after initial safety has been shown.

Participants receive a series of injections of the study drug into the tumor at scheduled visits, followed by regular medical examinations, imaging scans, and questionnaires that assess symptoms and overall well‑being. The study continues until the treatment plan is completed or until the disease progresses, with ongoing monitoring to record any side effects and changes in the tumor size.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you join the study, you will be asked to read and sign a consent form that explains the purpose of the trial and what will be required of you.

    You will provide your medical history and any current medications so the study team can confirm that you meet the eligibility criteria.

  2. Step 2

    Baseline assessments

    Before any treatment, you will undergo imaging tests such as ct or mri to document the size and location of the tumor.

    Blood samples will be taken to evaluate organ function and baseline laboratory values.

    You will complete a quality of life questionnaire (eortc qlq-c30) to record how you feel before treatment begins.

  3. Step 3

    First intratumoral injection

    The study medication, cy-101, contains the active substance getacatetide and is supplied as a solution for injection.

    The injection is given directly into the tumor (intratumoral route) by a qualified health professional.

    The dose may be either 20 mg/ml or 40 mg/ml, as determined by the study protocol and your treating physician.

    The injection is administered as a single dose during this visit.

  4. Step 4

    Immediate post‑injection monitoring

    After the injection you will be observed for a few hours to monitor for any immediate side effects.

    Vital signs and any symptoms will be recorded before you are allowed to leave the clinic.

  5. Step 5

    Scheduled follow‑up visits

    You will return to the clinic at regular intervals (for example, every four weeks) for follow‑up assessments.

    Each visit includes repeat imaging to assess tumor response, blood tests to check safety, and another quality of life questionnaire.

    The study team will also ask about any side effects you may have experienced since the last visit.

  6. Step 6

    Additional intratumoral injections (if required)

    Based on the trial protocol and your individual response, you may receive additional intratumoral injections of cy-101 at later visits.

    The same dosage (either 20 mg/ml or 40 mg/ml) and administration method will be used for each subsequent injection.

  7. Step 7

    Final assessment and end of trial

    Once the planned treatment period is completed, you will undergo a final set of imaging studies, blood tests, and a last quality of life questionnaire.

    The results will be used to evaluate the overall effect of the treatment and any lasting side effects.

Who can join the trial?

16 criteria

  • Written informed consent signed and dated, and the ability to cooperate with the study medication and follow‑up visits.
  • Diagnosis of adrenocortical carcinoma (ACC) confirmed by tissue testing, that is either locally advanced and cannot be removed by surgery or has spread (metastatic), and shows disease progression after the most recent treatment.
  • Have received at least one but no more than two prior lines of systemic therapy for advanced disease, including treatment with the drug mitotane at an adequate dose (blood level ≥ 14 mg/L or the highest dose you could tolerate). Treatments that did not reach this level do not count.
  • At least one tumor spot that can be measured according to RECIST criteria (a standard way doctors judge tumor size) and a separate tumor spot that can be safely injected with the study drug using ultrasound guidance. The injectable spot must be large enough to hold the required 4 mL volume.
  • Enough tumor tissue available for laboratory testing, and agreement to have a biopsy taken before treatment and another during treatment, unless this is deemed unsafe or not possible.
  • Expected to live at least 12 weeks from the time of enrollment.
  • An ECOG performance status of 0, 1, or 2 (a scale that measures how well you can carry out daily activities, where 0 means fully active and 2 means up and about more than 50 % of waking hours).
  • Blood and chemistry test results within the required ranges:
    • Hemoglobin (Hb) ≥ 90 g/L
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
    • Platelet count ≥ 100 × 10⁹/L
    • Total bilirubin ≤ 1.5 × the normal upper limit (≤ 3 × if you have Gilbert’s syndrome)
    • ALT and AST (liver enzymes) ≤ 2.5 × the normal upper limit (≤ 5 × if liver metastases are present)
    • Estimated creatinine clearance ≥ 50 mL/min (a measure of kidney function)
    • Albumin ≥ 28 g/L
    • Coagulation tests (PT/INR and aPTT) < 1.5 × the normal upper limit
    • Age 18 years or older at the time you sign the consent form.

Who cannot join the trial?

26 criteria

  • Receiving radiation therapy (except for pain relief), hormone therapy, chemotherapy, or any other study drug within the last 28 days or five times the drug’s half‑life (whichever is longer) before the first dose of CY‑101.
  • Continuing the drug mitotane unless you have a therapeutic blood level of at least 14 mg/L or are taking the highest dose you can tolerate; lower levels are not allowed.
  • Testing positive for hepatitis B (HBV) or hepatitis C (HCV) infection (previous exposure to HCV without current infection is allowed).
  • Having untreated HIV infection. Controlled HIV is allowed only if you are on a stable antiretroviral regimen for at least 4 weeks, have a viral load under 400 copies/mL, a CD4+ count of 350 cells/µL or higher, and no serious infection in the past year.
  • Being allergic or hypersensitive to any ingredient in the CY‑101 formulation.
  • Having serious heart problems, such as heart failure needing medication, a left‑ventricular ejection fraction (LVEF) below 40 %, a heart attack or unstable chest pain within the past 6 months, severe valve disease, or a major irregular heartbeat within the past 6 months.
  • Having received extensive radiation to more than 25 % of your bone marrow within the past 12 weeks.
  • Participating in another interventional clinical trial at the same time.
  • Having another active cancer, except for certain early‑stage skin cancers or cervical cancer that was fully treated, or a prior cancer that has been cured and has shown no signs for at least 5 years.
  • Having a congenital (present at birth) immune‑deficiency disorder.
  • Having an active autoimmune disease that needed strong medicines (like disease‑modifying drugs, steroids, or other immune‑suppressing drugs) in the past 2 years.
  • Using systemic (body‑wide) steroids or other immune‑suppressing medicines, except for low‑dose replacement steroids (up to 10 mg of prednisolone daily, or up to 20 mg if you are also on mitotane). Topical or inhaled steroids are allowed.
  • Having previously been treated with a Wnt inhibitor drug.
  • Having had a severe reaction to cancer immunotherapy that required intravenous steroids or other immune‑suppressing treatment, or that caused you to stop the therapy.
  • Receiving a live, weakened (attenuated) vaccine within 28 days before the first CY‑101 dose.
  • Having a bleeding disorder or taking blood‑thinning (anticoagulant or antiplatelet) medicines, except for low‑dose aspirin or preventive low‑molecular‑weight heparin.
  • Having a high burden of metastatic disease, defined as cancer spread to four or more organs or more than 12 separate metastatic sites (including the original tumor) on CT or MRI scans.
  • Having uncontrolled hormone excess (for example, Cushing’s syndrome or too much mineralocorticoid hormone) that causes uncontrolled high blood pressure, diabetes, or low potassium, as judged by the doctor.
  • Any other medical condition that the investigator believes would make participation unsafe or not in your best interest.
  • Having ongoing side effects from previous cancer treatments that are worse than mild (greater than CTCAE Grade 1), except for hair loss of any grade or moderate nerve tingling (Grade 2 peripheral neuropathy) if they are stable.
  • Having cancer that has spread to the brain or spinal cord (CNS metastases) unless it has been treated, is symptom‑free, stable on scans for at least 4 weeks, and you have been off steroids for 4 weeks.
  • Being pregnant, breastfeeding, or planning to breastfeed.
  • Being a woman who could become pregnant (child‑bearing potential) and not using reliable birth control, unless you have a negative pregnancy test within 7 days before starting and agree to follow the study’s contraception rules.
  • Being a man with a partner who could become pregnant and not using reliable birth control, unless you agree to follow the study’s contraception rules.
  • Having had major surgery from which you have not yet fully recovered.
  • Having a high medical risk from other serious non‑cancer illnesses, including an active uncontrolled infection.
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Investigated drugs

CY-101 is an experimental therapy being tested for patients with advanced or metastatic adrenocortical carcinoma. It is injected directly into the tumor (intratumoral administration) as a sterile liquid solution. The medication contains a substance called GETACATETIDE, which is designed to act on the tumor cells and may help the body’s immune system recognize and attack the cancer. In this trial, researchers are looking for the best amount to give and to see whether the therapy can shrink or stop the growth of the tumors.

What is already known about the treatment

CY-101 - This medication is supplied as a sterile solution for injection that is administered directly into the tumor (intratumoral) at concentrations of 20 mg/ml or 40 mg/ml. It is currently an investigational drug being studied in Phase II clinical trials and is not yet approved for general medical use. The drug is being tested for patients with locally advanced or metastatic adrenocortical carcinoma, a rare cancer of the adrenal gland. It works as a synthetic peptide that attaches to specific receptors on cancer cells, helping to trigger cell death and to activate the body’s immune response, and is classified as an experimental peptide‑based anticancer therapy.

Investigated diseases

Adrenocortical carcinoma - Adrenocortical carcinoma is a malignant tumor that arises from the outer layer of the adrenal glands. It may grow locally, invading nearby tissues such as the kidney or liver. In many cases the cancer spreads through the bloodstream to distant sites like the lungs, bones, or brain, which is described as metastatic disease. The tumor can increase in size over time, causing the adrenal gland to enlarge. As it progresses, it can affect hormone production, leading to hormonal changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522757-19-00Protocol codeCRUKD/25/001Estimated enrolment41 patientsSponsorCancer Research UK

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