Study on the Safety and Effects of EIK1004 for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is studying EIK1004 (also called IMP1707) in patients with advanced solid tumors. The study focuses on specific types of cancers, including endometrioid ovarian cancer, fallopian tube cancer, primary peritoneal cancer, HER2-negative breast cancer, metastatic castration-resistant prostate cancer, and metastatic pancreatic ductal adenocarcinoma. The purpose is to evaluate the safety, tolerability, and activity of EIK1004 when given as a single medication (monotherapy).

The study is designed in multiple parts. Part 1 focuses on finding the maximum tolerated dose or maximum administered dose and the recommended dose for further evaluation. Part 2 continues to assess safety and tolerability at the established dose. Participants must have specific genetic mutations in genes such as BRCA1, BRCA2, PALB2, RAD51B, RAD51C, or RAD51D. These are genes involved in DNA repair, and mutations in these genes may make cancer cells more susceptible to certain treatments.

The trial is “open-label,” which means both doctors and patients know which treatment is being given. Patients will receive the medication orally (by mouth) and will be monitored for side effects and response to treatment. Some patients with brain metastases (cancer that has spread to the brain) may also be eligible to participate under specific conditions.

1 Study Start

After qualifying for the study and completing screening procedures, you will begin participation in this clinical trial for EIK1004, a medication being tested for advanced solid tumors.

This study has two parts: Part 1 focuses on finding the right dose, and Part 2 examines how well that dose works. Your participation will be in either Part 1 or Part 2, depending on when you join the study.

2 Medication Administration

You will take EIK1004 tablets by mouth. The tablets come in 5mg and 20mg strengths.

In Part 1 (dose-finding), different participants may receive different doses to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended dose for expansion (RDE).

The exact dosage and schedule will be provided by your study doctor, who will monitor your response to the medication throughout the trial.

3 Safety Monitoring

Throughout the study, you will have regular medical appointments to monitor how your body responds to EIK1004.

Your study team will track any side effects, which are called adverse events (AEs). They will pay special attention to dose-limiting toxicities (DLTs), which are side effects that might require changing your dose.

Blood samples will be collected to measure the amount of EIK1004 in your body after single and multiple doses. This is called pharmacokinetics (PK) testing.

4 Effectiveness Monitoring

You will have regular imaging scans to check if your tumors are responding to treatment.

The study team will measure several aspects of your response:

• Objective Response: Whether your tumors shrink

• Disease Control: Whether your cancer stays stable or improves

• Duration of Response: How long any improvement lasts

• Time to Response: How quickly your cancer responds to treatment

If you have brain metastases (cancer that has spread to the brain), the team will also track the Time to CNS progression, which measures how long it takes before cancer in the central nervous system worsens.

5 Ongoing Treatment

You will continue taking EIK1004 as long as you are benefiting from treatment and not experiencing unacceptable side effects.

If you were receiving hormone therapy (such as ADT for prostate cancer) before starting the study, you will continue this treatment during the study.

Throughout your participation, your study doctor will closely monitor your condition and may adjust your treatment as needed.

6 Study Completion

Your participation will end if your disease progresses, you experience unacceptable side effects, you decide to withdraw, or the study ends.

The entire study is expected to run until July 2027, though individual participation length will vary based on your response to treatment.

After your last dose of the study medication, you may have follow-up visits to check your health status.

Who Can Join the Study?

You must volunteer to participate and follow all study procedures.
You must be at least 18 years old.
You must have one of these cancer types:
- Advanced, recurrent, or metastatic (spread to other parts of the body) endometrioid ovarian, fallopian tube, or primary peritoneal cancer with at least 1 prior chemotherapy
- Advanced, recurrent, or metastatic HER2-negative breast cancer with at least 1 prior chemotherapy
- Metastatic castration-resistant prostate cancer (mCRPC) with ongoing hormone therapy
- Advanced, recurrent, or metastatic pancreatic cancer with prior treatment
You must have mutations (changes in DNA) in one of these genes: BRCA1, BRCA2, PALB2, RAD51B, RAD51C or RAD51D.
You must have cancer that has been shown to be growing (progressing) on scans.
For prostate cancer patients, increasing PSA levels (a blood test that can indicate prostate cancer activity) is acceptable.
You must have an ECOG Performance Status of 0 to 1 (able to perform daily activities with minimal or no assistance).
Your life expectancy must be at least 12 weeks.
You must have adequate organ function.
Female participants must either:
- Be unable to have children, or
- Be post-menopausal (no longer having menstrual periods), or
- Have a negative pregnancy test and use effective birth control if able to become pregnant
Male participants must have had a vasectomy or use effective birth control methods from the start of the study until 6 months after the last dose.
For patients previously treated with PARP inhibitors (a type of cancer drug), up to 1 prior treatment is allowed (Part 1 only).
If you have cancer that has spread to the brain (CNS metastases), you must meet specific requirements about your brain lesions and their treatment.

Who Cannot Join the Study?

Having received another anti-cancer therapy within 28 days before starting the study treatment.
Having had major surgery within 28 days before the first dose of the study drug.
Having active or untreated brain metastases (cancer that has spread to the brain).
Having received a live vaccine within 30 days before starting the study treatment.
Having a history of allergic reactions to similar drugs.
Having an active infection requiring treatment.
Being pregnant or breastfeeding.
Having unstable heart disease.
Having been diagnosed with another cancer within the past 3 years (except for certain skin cancers or cancers considered cured).
Having serious uncontrolled medical disorders that could affect your participation in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Clinico San Carlos	Madrid	Spain
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
MD Anderson Cancer Center	Madrid	Spain
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Institut Godinot	Reims	France
Hospital Da Luz S.A.	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Rigshospitalet	Copenhagen	Denmark
Iiwgnijh Cagawy Dxrsysskaadnvduqn	L'hospitalet De Llobregat	Spain
Pbxc Tozse Hnduqnur Useijugunwti	Sabadell	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	15.07.2025
France	Recruiting	15.07.2025
Portugal	Recruiting	15.07.2025
Spain	Recruiting	15.07.2025

Trial locations

EIK1004 (IMP1707) is an investigational medication being studied for the treatment of advanced solid tumors. It is administered as a monotherapy, which means it is given alone without other cancer treatments. The study aims to find the appropriate dosage that is both safe and potentially effective for patients with advanced solid tumors.

Advanced solid tumors – A term referring to cancers that have formed a solid mass of cells and have progressed to an advanced stage. These tumors originate in various tissues and organs throughout the body, such as the breast, lung, colon, prostate, or pancreas. In advanced stages, the cancer has typically grown larger in its original location and may have spread (metastasized) to nearby tissues, lymph nodes, or distant parts of the body. Advanced solid tumors are characterized by abnormal cell growth that continues uncontrollably, eventually interfering with normal bodily functions. The specific symptoms vary widely depending on the tumor’s location and extent of spread.

Trial ID:

2024-520395-99-00

Protocol code:

EIK1004-001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effects of EIK1004 for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?