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Study of IMP1734, Paclitaxel, and Abiraterone for Patients with Advanced Solid Tumors

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for advanced solid tumors, which are cancers that have spread beyond their original location. The treatment being tested is a medication called IMP1734, which is a type of drug known as a PARP1 selective inhibitor. This medication is being studied both on its own and in combination with other cancer-fighting drugs. The study aims to understand how safe and tolerable IMP1734 is for patients, as well as how it behaves in the body and its potential to fight tumors.

Participants in the study will receive IMP1734, and some may also receive other medications such as Paclitaxel, Abiraterone, or Prednisolone. Paclitaxel is commonly used in cancer treatment and works by stopping cancer cells from dividing. Abiraterone is used to treat prostate cancer by reducing the production of certain hormones. Prednisolone is a steroid that can help reduce inflammation and is often used in cancer therapy. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study will take place over several phases, starting with a small group of participants to determine the best dose of IMP1734. As the study progresses, more participants will be included to further evaluate the treatment's effectiveness and safety. Throughout the study, participants will be closely monitored for any side effects and changes in their cancer. The ultimate goal is to find out if IMP1734 can be a safe and effective treatment option for people with advanced solid tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to evaluate eligibility. This includes a review of medical history and current health status.
Participants must have advanced solid tumors and meet specific health criteria, including adequate organ function and a life expectancy of at least 12 weeks.
Step 2
Treatment phase 1
The first phase involves the administration of the study drug, IMP1734, to evaluate its safety and tolerability.
Participants receive IMP1734 as a monotherapy, meaning it is given alone without other medications.
Step 3
Combination therapy
In the next phase, IMP1734 is administered in combination with other anti-cancer agents to assess safety and determine the optimal dose.
The combination may include medications such as paclitaxel (intravenous), eik1003 (oral), abiraterone (oral), and prednisolone (oral).
Step 4
Dose optimization
This phase focuses on optimizing the dose of IMP1734 to ensure maximum effectiveness with minimal side effects.
Participants are closely monitored for any adverse reactions and adjustments to the dosage may be made based on individual responses.
Step 5
Dose expansion
The dose expansion phase aims to further evaluate the anti-tumor activity of IMP1734 at the determined optimal dose.
Participants continue to receive the study drug, and their response to treatment is assessed through various medical evaluations.
Step 6
Follow-up
After completing the treatment phases, participants enter a follow-up period to monitor long-term effects and overall health.
Regular check-ups and assessments are conducted to gather data on the efficacy and safety of the treatment.

Who can join the trial?

21 criteria

Participants must agree to join the study and follow the study procedures.
Female participants should meet at least one of these conditions:
- Cannot have children.
- Are post-menopausal, meaning they have stopped having periods.
- If they can have children, they must have a negative pregnancy test, not be breastfeeding, and agree to use very effective birth control.
- Male participants must have had a vasectomy or use very effective birth control methods from the start of the study until six months after the last dose of the study drug.
- Participants who have been treated with PARPi (a type of cancer treatment) or have never received it are eligible. Those treated with PARPi can have had only one prior PARPi treatment (Part 1 only).
- Participants with certain types of cancer (EOC, fallopian tube, or primary peritoneal cancer) must have had only one prior PARPi treatment (Part 2 only).
- Participants with EOC, fallopian tube, or primary peritoneal cancer should respond well to platinum-based treatments (Part 3 only).
- Breast cancer participants can join if their cancer has not worsened. If they had platinum-based chemotherapy before, at least 12 months must have passed since that treatment and the first dose of the study drug (Part 3 only).
- No prior therapy with a PARPi is allowed for certain participants (Part 3 Cohort 3A only).
- Participants must be at least 18 years old.
- Participants must have one of the following confirmed conditions:
  - Advanced or recurrent cancer of the endometrium, fallopian tube, or primary peritoneal cancer, with specific treatment history and disease characteristics.
  - Advanced or recurrent HER2-negative breast cancer, with specific treatment history and disease characteristics.
  - Advanced prostate cancer, with specific treatment history and disease characteristics.
  - Advanced pancreatic cancer, with specific treatment history and disease characteristics.
  - Participants must have harmful or potentially harmful genetic mutations.
  - Participants with measurable disease must have documented cancer progression before joining the study. Prostate cancer limited to certain areas is not eligible.
  - For prostate cancer, progression based on PSA levels is acceptable.
  - Participants must have an ECOG Performance Status of 0 to 1, which means they are fully active or have some symptoms but can still do light work.
  - Participants must have a life expectancy of at least 12 weeks.
  - Participants must have proper organ function.

Who cannot join the trial?

5 criteria

Patients with certain types of cancer that are not classified as advanced solid tumors cannot participate. Advanced solid tumors are cancers that have spread and formed solid masses in the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely tolerate the study medication or its combination with other anti-cancer drugs cannot participate.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who are part of a vulnerable population that the study cannot safely include cannot participate. A vulnerable population refers to groups of people who may be at higher risk of harm or exploitation.

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Verified sites

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

Verified
Centre Francois Baclesse
Caen, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

IMP1734 is a new medication being studied for its potential to treat advanced solid tumors. It is a selective inhibitor of an enzyme called PARP1, which is involved in repairing damaged DNA in cells. By inhibiting this enzyme, IMP1734 may help to prevent cancer cells from repairing themselves, potentially leading to their death. This study is exploring the safety and effectiveness of IMP1734 both on its own and in combination with other anti-cancer medications.

What is already known about the treatment

IMP1734 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is in the early stages of research, specifically in a Phase 1/2 trial, to assess its safety, tolerability, and effectiveness. IMP1734 is a selective inhibitor of the enzyme PARP1, which plays a role in repairing damaged DNA in cells. By inhibiting PARP1, the medication aims to prevent cancer cells from repairing themselves, leading to their death. It falls under the pharmacological classification of PARP inhibitors, which are a type of targeted cancer therapy.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that have progressed to a late stage, where the cancer cells form solid masses or tumors in various organs. These tumors can occur in different parts of the body, such as the lungs, liver, pancreas, or colon. As the disease progresses, the tumors may grow larger and spread to other parts of the body, a process known as metastasis. This can lead to the impairment of normal organ function and cause a variety of symptoms depending on the location of the tumors. The progression of advanced solid tumors can vary greatly between individuals, influenced by factors such as the type of cancer, its location, and the overall health of the patient.