Not yet recruiting

Study of IDE849, IDE‑161 and durvalumab evaluating safety and efficacy in patients with DLL3‑positive tumors including small cell lung cancer

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on cancers that have a protein called DLL3 on their surface, which includes Small Cell Lung Cancer. Participants receive the investigational drug IDE849, given as an intravenous solution, and may also receive the oral medication IDE-161 and the approved antibody therapy durvalumab delivered by infusion. The goal is to find a dose that is safe and to see whether the medicines can shrink or stop the growth of these tumors.

The purpose of the trial is to evaluate safety and anti‑tumor activity of the study drugs. In the first part, increasing doses are tested to identify the highest amount that does not cause unacceptable side effects, while in the second part the selected safe dose is used to further assess how the drugs affect the cancer. Participants attend regular clinic visits for treatment administration, blood tests to study how the drug moves through the body (pharmacokinetics), and imaging scans that are measured using the RECIST criteria, a standard way to judge changes in tumor size. Any side effects are recorded and graded with the CTCAE system, which classifies their seriousness from mild to severe.

The research process

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

Step 1
Baseline assessments
After joining the study, a series of baseline examinations are performed to confirm eligibility. these include physical examination, laboratory tests, and imaging studies of the tumor.
The results are used to document the initial condition of the dll3 expressing tumor and to establish reference values for later safety and efficacy evaluations.
Step 2
Initiation of treatment cycle – part 1 (dose‑escalation)
On day 1 of the first treatment cycle, an intravenous infusion of ide849 is administered. the exact dose is determined by the study protocol and may be increased in subsequent cycles to identify the highest safe dose.
If the protocol includes combination therapy, a second intravenous infusion of durvalumab may be given on the same day.
An oral tablet of ide-161 is taken each day as prescribed, with the dose and frequency defined by the protocol.
Step 3
Safety monitoring during part 1
After each infusion, vital signs and any immediate side effects are recorded.
Blood samples are collected regularly to measure drug levels and to check for adverse reactions.
Clinic visits are scheduled at defined intervals (for example, weekly or bi‑weekly) to assess the incidence and severity of side effects, including dose‑limiting toxicities.
Step 4
Transition to part 2 (dose‑expansion)
If the dose identified in part 1 is considered safe, the patient continues receiving ide849 at that dose, either alone or with the combination drugs used in part 1.
The schedule of infusions and oral tablets remains the same as described for part 1, unless the protocol specifies a different frequency.
Step 5
Ongoing efficacy and safety evaluations
Periodic imaging studies are performed to evaluate tumor response, using criteria that define objective response and duration of response.
Additional laboratory tests continue to monitor organ function and to detect any new adverse events.
The patient may have regular visits every 3 to 6 weeks, depending on the study schedule, to review results and adjust treatment if necessary.
Step 6
Treatment discontinuation
Treatment is stopped if disease progression is observed, if unacceptable toxicity occurs, or when the study reaches its planned end date.
The decision is based on the predefined criteria outlined in the protocol.
Step 7
Post‑treatment follow‑up
After discontinuation, follow‑up visits continue for a period defined by the study to monitor long‑term safety and any lasting effects of the therapy.
These visits may include physical examinations, laboratory tests, and imaging to assess the patient’s condition.

Who can join the trial?

17 criteria

Agree to join the study, understand what will happen, and sign the written consent form.
Women who could become pregnant must use a highly effective method of contraception (failure rate < 1% per year), have a negative pregnancy test before the first dose, and not be breastfeeding; their male partners must also use effective contraception.
Be at least 18 years old and be male or female.
Have a confirmed diagnosis of a tumor that shows DLL3 expression, such as extensive‑stage small cell lung cancer (SCLC), high‑grade neuroendocrine cancers of the gastrointestinal tract, prostate, lung, skin (Merkel cell), or other solid tumors that have progressed after standard treatment.
Have disease that has gotten worse after standard treatments, including platinum‑based chemotherapy and drugs that block PD‑1/PD‑L1 (immunotherapy), and have received no more than three lines of systemic therapy for extensive disease (exceptions allowed).
Be able to give a tumor tissue sample (a block of tissue or at least 20 unstained slices) for laboratory testing.
Have at least one tumor lesion that can be measured according to RECIST version 1.1 (a standard way doctors measure tumor size).
Have an ECOG performance status score of 0 or 1 (meaning you are fully active or able to carry out light work).
Have a life expectancy of more than three months.
Have adequate blood‑forming (bone marrow) and organ function, which means:
- White‑blood‑cell count (neutrophils) ≥ 1.5 × 10⁹/L.
- Platelet count ≥ 100 × 10⁹/L.
- Hemoglobin (red‑blood‑cell protein) ≥ 9.0 g/dL.
- Albumin (a protein made by the liver) ≥ 3.0 g/dL.
- Liver enzymes (ALT and AST) ≤ 3 times the normal upper limit (≤ 5 times if you have liver metastases).
- Bilirubin (a waste product processed by the liver) ≤ 1.5 times the normal limit (≤ 3 times if you have Gilbert’s syndrome).
- Kidney function measured by creatinine clearance ≥ 60 mL/min (or 50–60 mL/min with special approval).
- Blood clotting tests (INR and aPTT) ≤ 1.5 times the normal limit; stable use of blood thinners is allowed if tests are in the therapeutic range.

Who cannot join the trial?

26 criteria

Diagnosis of a mixed tumor that has both small cell lung cancer (SCLC) and non‑small cell lung cancer features; patients with limited‑stage SCLC are also not allowed.
History of immune system problems, such as a positive HIV test with detectable virus levels.
Active viral hepatitis: positive test for hepatitis B surface antigen or core antibody with high viral DNA, or positive hepatitis C antibody with detectable virus.
Active tuberculosis within the past year, or past tuberculosis that was not treated properly.
Severe side effects from previous cancer treatment that have not improved to mild (≤ Grade 1), except for hair loss.
If receiving the drug durvalumab, any prior heart inflammation (myocarditis) of Grade 2 or higher, or any immune‑related side effect of Grade 3 or higher; any prior immune‑related side effect must have fully resolved to less than Grade 1.
If receiving the drug IDE161, previous removal of the stomach or upper intestine, or gastrointestinal disorders such as Crohn’s disease or ulcerative colitis that could affect drug absorption.
Recent cancer therapies: chemotherapy within 3 weeks, immunotherapy or targeted biologic therapy within 2 weeks, small‑molecule drugs within 2 weeks (or five drug half‑lives), or other investigational products within 4 weeks (or five half‑lives). Patients who just finished immunotherapy must show documented tumor progression before starting the study drug.
Use of strong enzyme‑affecting medicines (strong CYP3A4 or CYP2D6 inhibitors/inducers), strong P‑gp or BCRP inhibitors, or medicines that can cause QT prolongation, within 2 weeks (or five half‑lives) before the first dose.
For the IDE161 combination: use of narrow‑therapeutic‑index drugs that are substrates of MATE2‑K, BCRP, or P‑gp within 2 weeks; strong CYP3A4/5 inducers or inhibitors within 2 weeks; proton‑pump inhibitors (e.g., omeprazole) within 7 days; H2‑blocking agents within 10‑12 hours; antacids within 2 hours; or QT‑prolonging drugs within five half‑lives before the first dose.
Prior treatment with a DLL3 antibody‑drug conjugate that contains a topoisomerase I inhibitor, or any previous topoisomerase I inhibitor therapy.
History of intolerance to PD‑1/PD‑L1 inhibitors (relevant for the durvalumab combination).
Untreated or active cancer spread to the brain or spinal cord (CNS metastasis). Small, symptom‑free brain metastases may be considered after discussion, but leptomeningeal spread (cancer in the lining of brain/spinal cord) is excluded. Treated brain metastases are allowed if stable.
Received more than 30 Gy of chest radiation within the last 12 weeks, or more than 30 Gy of non‑chest radiation within the last 4 weeks (except certain recent brain radiation).
Major surgery or serious injury within 4 weeks before the first dose, or planned elective surgery during the study period.
Received a live attenuated vaccine within 28 days before the first dose, or expected to receive one during the study.
Women who are pregnant, breastfeeding, or planning to become pregnant.
Known allergy to any part of the study drug or a history of severe allergic reactions to similar biologic medicines.
Other factors that could affect safety or study results, such as alcohol or drug abuse, serious other illnesses, major laboratory abnormalities, or social issues.
Other cancers diagnosed within the past 2 years, except low‑risk cancers such as in‑situ cervical cancer, basal cell skin cancer, localized prostate cancer after surgery or radiation, certain breast or thyroid cancers that have been fully treated.
Uncontrolled tumor‑related pain; pain medication must be on a stable regimen before entering the study.
Severe heart or blood‑vessel disease, including uncontrolled high blood pressure (SBP >150 mm Hg or DBP >100 mm Hg), serious heart rhythm problems, recent heart attack or heart failure (NYHA class ≥ 2), aortic dissection, recent blood clots, left‑ventricular ejection fraction <50%, or a prolonged QT interval (>470 ms).
Significant bleeding within the last 3 months, or coughing up ≥2.5 mL of blood repeatedly in the month before enrollment.
Uncontrolled fluid buildup around the lungs, abdomen, or heart (pleural, peritoneal, or pericardial effusion) within 2 weeks that requires repeated drainage.
History of interstitial lung disease (pneumonitis) from prior treatment, current non‑infectious lung inflammation needing steroids, or other moderate‑to‑severe lung diseases that seriously affect breathing within the past 3 months.
Severe infections within 4 weeks before starting treatment, such as bloodstream infection, serious pneumonia, or any infection requiring hospitalization and systemic antibiotics.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

IDE849
is an investigational drug given by a needle into a vein as a liquid that can be mixed for injection. In this study, it is being tested to see if it can safely treat tumors that have a protein called DLL3. Researchers are looking at how well patients tolerate the medicine and whether it can help shrink or stop the growth of the cancer.
IDE161
is an experimental tablet that patients swallow. It is also being studied for its ability to treat DLL3‑positive tumors. The trial examines whether taking this pill, either by itself or together with other medicines, is safe and can help control the cancer.
IMFINZI
(durvalumab) is a medicine that is already approved for some cancers. It is given through an IV infusion, which means it is slowly delivered into a vein over time. In this trial, it is used as a background therapy to see how it works together with the new drugs being tested, and to help the immune system attack the tumor.

Durvalumab

What is already known about the treatment

IDE849
This medication is given as an intravenous injection of a clear solution. It is still experimental and currently only appears in early clinical studies. It is being tested for tumors that have the DLL3 protein, such as small cell lung cancer. It works by attaching to DLL3 on cancer cells and delivering a cell‑killing agent, placing it in the class of antibody‑drug conjugates.
IDE161
This drug is taken as an oral tablet. It is also investigational and is currently being evaluated in clinical trials. It is studied for the same DLL3‑positive tumors, including small cell lung cancer. It acts as a small‑molecule agent that blocks a growth‑promoting pathway in cancer cells, making it a targeted therapy.
IMFINZI
This medicine is administered by intravenous infusion of a solution for infusion. It is an approved cancer treatment that is widely described in medical literature. It is used for several cancers, including lung cancer, and works by blocking the PD‑L1 protein so the immune system can recognize and attack tumor cells. It belongs to the class of monoclonal antibodies known as immune checkpoint inhibitors.

Investigated diseases

Small cell lung cancer - Small cell lung cancer is a fast‑growing cancer that starts in the lung’s airway cells. It often spreads quickly to other parts of the body such as the lymph nodes, liver, brain, and bones. The disease usually begins with symptoms like coughing, shortness of breath, or chest discomfort. As it progresses, patients may notice weight loss, fatigue, and new symptoms related to affected organs. The cancer cells often produce a protein called DLL3, which can be used to identify the tumor. Over time, the tumor can become larger and cause more severe breathing problems.