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Phase 1/2 Study of ter-2013-01, imlunestrant, and fulvestrant in patients with solid tumors with AKT/PI3K/PTEN pathway alterations

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on patients with solid tumors that have changes in the AKT/PI3K/PTEN pathway. These changes are genetic alterations that can make cancer cells grow faster. One specific group included is HR+/HER2− breast cancer, a type of breast cancer that responds to hormones but does not have excess HER2 protein. The investigational medicine is called TER-2013, which is taken as an oral tablet. In some parts of the study the tablet is given together with an injectable hormone‑blocking drug, fulvestrant, which is administered as an injection.

The purpose of the study is to assess how safe the medicine is and whether it shows early signs that it can shrink tumors when used alone or with the hormone blocker. Participants start with low doses that are gradually increased while doctors watch for side effects, known as dose‑limiting toxicities, and determine the highest dose that can be given safely, called the maximum tolerated dose. After the safe dose is found, more patients receive that dose for several treatment cycles, with regular clinic visits, blood tests, and imaging scans to see if the tumors are responding. The study follows a phase 1/2 trial design, beginning with a safety‑focused part and then moving to a larger group to look at tumor response and how long the benefit lasts.

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

    Baseline assessments

    After joining the study, you will undergo a series of initial examinations, including physical checks, blood tests, and imaging scans to document the current status of your solid tumor.

    The results serve as the reference point for all later safety and effectiveness evaluations.

  2. Step 2

    Start of <b>ter-2013</b> monotherapy

    You will receive ter-2013 tablets taken by mouth. the exact amount of each tablet and how many times per day will be set by the study protocol and may be increased gradually during the dose‑escalation phase.

    The medication is continued for multiple treatment cycles unless safety concerns arise.

  3. Step 3

    Dose escalation and safety monitoring

    During the early part of the trial, the dose of ter-2013 is raised step by step to find the highest amount that can be tolerated without causing serious side effects.

    Each increase is followed by close observation for adverse events, laboratory changes, and any dose‑limiting toxicities (serious side effects that stop further dose increases).

  4. Step 4

    Combination lead‑in with <b>fulvestrant</b>

    Once a safe dose of ter-2013 is identified, you will begin receiving fulvestrant, an injectable medication given into a muscle.

    The injection schedule follows the study plan, typically every four weeks, while you continue taking ter-2013 tablets.

    The purpose is to evaluate safety when the two drugs are used together.

  5. Step 5

    Cohort expansion and continued treatment

    After the combination safety phase, you may enter an expansion cohort where the established dose of ter-2013 (with or without fulvestrant) is given for a longer period.

    Regular tumor assessments are performed to look for signs of response, such as tumor shrinkage or disease stabilization.

  6. Step 6

    Ongoing efficacy and safety visits

    Throughout the trial, you will attend scheduled clinic visits for physical exams, blood work, and imaging to monitor both side effects and how the tumor is responding.

    Any new symptoms or laboratory changes are recorded and evaluated by the study team.

  7. Step 7

    Treatment discontinuation and follow‑up

    Treatment may stop if disease progression occurs, unacceptable toxicity develops, or the planned treatment period ends.

    After stopping the study drugs, you will continue to be followed for a defined period to assess long‑term safety and survival outcomes.

Who can join the trial?

15 criteria

  • Age: You must be 18 years old or older.
  • Prior therapies: You must have already received the standard treatments that are appropriate for your type and stage of cancer and have no standard‑of‑care treatments left, unless they were not suitable, you could not tolerate them, or you chose not to receive them.
  • Specific prior treatments for expansion cohorts: If you have ovarian cancer, you must have had platinum‑based chemotherapy before; for cervical, head‑and‑neck, lung, esophageal, or endometrial cancer you must have had at least one standard treatment for recurrent or metastatic disease, and you cannot have had more than three prior treatments for advanced cancer.
  • Disease progression: Your cancer must have gotten worse after your most recent treatment.
  • Measurable disease (RECIST v1.1): You must have tumor lesions that can be measured or evaluated using a standard system (RECIST) that doctors use to track tumor size.
  • Life expectancy: Doctors must estimate that you will live at least 12 more weeks.
  • Blood clotting tests (PT/INR): Your prothrombin time (PT) or International Normalized Ratio (INR) must be 1.5 times the upper normal limit or less; if you are taking blood‑thinning medication, your activated Partial Thromboplastin Time (aPTT) must be within the therapeutic range.
  • Toxicity from previous therapy: Any side effects from earlier cancer treatments must have resolved to mild (grade 1) or returned to baseline levels.
  • ECOG performance status: You must have a score of 0 or 1 on the Eastern Cooperative Oncology Group scale, meaning you are fully active (0) or able to do light work but not physically strenuous activities (1).
  • Adequate organ function: Your bone marrow (blood‑forming tissue), kidneys, and liver must be functioning well enough for the study.
  • Ability to swallow: You must be able to swallow capsules or tablets.
  • Contraception: If you are a woman who could become pregnant or a man with a partner who could become pregnant, you must agree to use birth control during the study and for the required time after it ends.
  • Confirmed solid tumor with specific genetic change: Your cancer must be proven by tissue testing to be a solid tumor that has an eligible alteration in the AKT/PI3K/PTEN pathway, identified by a sponsor‑approved test on tumor tissue or blood‑derived DNA.
  • Metastatic or locally advanced, unresectable disease: Your cancer must have spread (metastatic) or be locally advanced and cannot be removed completely by surgery.
  • No curative treatment available: There must be no treatment option that can cure your cancer.

Who cannot join the trial?

17 criteria

  • If you have certain gene changes called EGFR, KRAS, NRAS, HRAS, or BRAF together with alterations in the PI3K/AKT/PTEN pathway, you cannot join the study unless the study doctors review your case specially.
  • If you have diabetes that requires insulin or your blood‑sugar level (A1c) is 8% or higher, you cannot join.
  • If cancer has spread to your brain or to the lining around the brain (called carcinomatous meningitis), you cannot join.
  • If you have a condition that causes your red blood cells to break down (known as a hemolysis disorder), you cannot join.
  • If you have another cancer that could be confused with the cancer being studied, or a second cancer that the doctor thinks is important, you cannot join.
  • If you are infected with HIV or have active hepatitis B or hepatitis C, you cannot join (unless the study protocol makes an exception).
  • If you have a disorder that prevents your body from absorbing food or medicines properly, or you have ongoing nausea or vomiting that cannot be controlled with medication, you cannot join.
  • If you are pregnant, breastfeeding, planning to become pregnant, or planning to breastfeed during the study or for the required time after the study drugs (6 months after TER‑2013 or 24 months after fulvestrant), you cannot join.
  • If you have a medical or mental‑health condition that the study doctor believes makes participation unsafe or would stop you from giving informed consent, you cannot join.
  • If you have an active infection that needs IV (through a vein) antibiotics, antivirals, or antifungal medicines, you cannot join (preventive antibiotics are allowed).
  • If you have serious heart problems such as uncontrolled irregular heartbeat (atrial fibrillation), moderate to severe heart failure (NYHA class 3 or higher), recent chest pain or heart attack (within the past 3‑6 months), a prolonged heart‑rhythm interval (QTc ≥ 450 ms) or a family history of Long QT syndrome, you cannot join.
  • If you have had a blood‑clot event such as a stroke, mini‑stroke (TIA), deep‑vein clot, or lung clot (pulmonary embolism) in the last 3 months, you cannot join (except for a treated catheter‑related clot that occurred more than 1 month ago).
  • If you have had significant coughing up of blood or major bleeding in the past 4 weeks, you cannot join.
  • If you have previously taken drugs that block the AKT/PI3K/PTEN pathway (specific targeted therapies), you may be excluded unless the study doctors give special approval.
  • If you received chemotherapy, immunotherapy, other cancer medicines, an experimental drug, or a procedure that blocks a tumor’s blood supply within 14 days before the first study dose, you cannot join (certain stable prostate‑cancer hormone treatments are allowed).
  • If you had palliative radiation therapy (radiation to relieve symptoms) within 14 days before the first study dose, you cannot join.
  • If you had major surgery or a serious injury in the past 28 days, or you are expected to need major surgery during the study, you cannot join (minor surgery or placement of a small vascular line is allowed if the wound is healed).
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Investigated drugs

  • TER-2013

    is an experimental oral tablet being studied for the first time in patients whose cancers have changes in the AKT/PI3K/PTEN pathway. In this trial the drug is given by mouth and is tested both by itself and together with other medicines that block estrogen receptors. The main goals are to see how safe it is, how much can be given without serious side effects, and whether it shows any signs that it can shrink or stop the growth of solid tumors.

  • Inluriyo

    is a film‑coated tablet that contains the active substance imlunestrant. It works by blocking estrogen receptors, which can help slow the growth of certain breast cancers that rely on estrogen signals. In this study the tablet is used as a comparator, meaning it is given to some participants to compare its effects and safety with those of the experimental drug TER‑2013.

  • Fulvestrant Ribosepharm

    is an injectable solution that contains fulvestrant. It is given by intramuscular injection and works by destroying estrogen receptors in the body, which can reduce the growth of hormone‑responsive breast cancers. In the trial it is used as a comparator and also combined with TER‑2013 to see if the two medicines together are safe and potentially more effective than either one alone.

What is already known about the treatment

  • TER-2013-01

    This investigational drug is taken as an oral tablet. It is currently being studied in early‑phase clinical trials for patients with solid tumors that have changes in the AKT/PI3K/PTEN pathway. The medicine aims to block signals that tell cancer cells to grow, acting as an AKT pathway inhibitor. It belongs to the experimental class of targeted cancer therapies.

  • Imlunestrant

    Imlunestrant is supplied as a film‑coated tablet taken by mouth. It is still in the investigational stage and is being evaluated as a comparator in trials for hormone‑sensitive breast cancer. The drug works by attaching to estrogen receptors and causing them to break down, which reduces the cancer‑promoting effects of estrogen. It is classified as a selective estrogen receptor degrader (SERD).

  • Fulvestrant

    Fulvestrant comes as a solution for intramuscular injection. It is an approved medication used to treat hormone‑receptor‑positive breast cancer. The agent binds to estrogen receptors and speeds up their removal from the cell, blocking estrogen‑driven tumor growth. It is categorized as an estrogen receptor antagonist and degrader (SERD).

Investigated diseases

  • Solid tumours

    Solid tumours are abnormal masses of cells that develop in organs or tissues such as the lung, liver, or colon. They begin as a small cluster of cells that grow and can push into surrounding tissue. Over time they may acquire the ability to spread through the bloodstream or lymphatic system to other parts of the body, forming new growths. This spread changes the disease from a localized mass to a more widespread condition. The growth pattern can vary, with some tumours expanding quickly while others grow slowly.

  • Hormone receptor‑positive, HER2‑negative breast cancer

    This breast cancer type has cells that respond to estrogen or progesterone but do not have excess HER2 protein. It usually starts as a lump in the breast that can enlarge gradually. As the disease advances, cancer cells may move into nearby lymph nodes and later travel to distant organs such as bone or liver. The hormone receptors can influence how the tumour grows, often leading to a slower progression compared with other breast cancer subtypes. The disease can shift from a breast‑confined tumour to a condition affecting multiple body sites.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-525036-34-00Protocol codeTER-2013-C01Estimated enrolment370 patients

sourced from the EU Clinical Trials Register and site verification

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