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Active not recruitingPHASE1INTERVENTIONAL

Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors

This is an early-stage clinical trial (Phase 1) looking into a new medication called MOMA-313 for people with advanced or metastatic solid tumours, which include some prostate, breast, and pancreatic cancers. Researchers want to understand if MOMA-313 is safe, what the right dose is, and how the body handles it. They are also looking for early signs of whether it could help treat these cancers. The study is particularly focused on tumours that have a specific genetic characteristic called 'homologous recombination deficiency'. MOMA-313 will be given by mouth, either on its own or in combination with an existing cancer drug called Olaparib. The information gathered from this study will help decide if MOMA-313 should be studied further in larger trials.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
MOMA Therapeutics
Enrolment target
220
Start
13 Aug 2024
Estimated completion
30 Nov 2027

What is this study about?

This study is an early research project, called a Phase 1 trial, designed to explore a new potential cancer treatment named MOMA-313. This new drug is being tested in people who have advanced or metastatic solid tumours. 'Advanced' means the cancer has grown or spread beyond its original site, and 'metastatic' means it has spread to other parts of the body. Cancers included in this study are prostate, breast, and pancreatic cancer, among others.

The main goals of this initial study are to understand how safe MOMA-313 is, how well people tolerate it, and what the best dose might be. Researchers also want to see how the drug moves through and affects the body, and if there are any early hints that it could shrink tumours or slow their growth. MOMA-313 is designed to attack cancers that have a specific genetic weakness, known as 'homologous recombination deficiency'. The drug works by blocking a particular protein (DNA polymerase theta) involved in repairing cell damage, which can be a key weakness in these types of cancer.

Participants will receive MOMA-313 by mouth. Some will get MOMA-313 on its own, while others will receive it alongside another cancer drug called Olaparib. Olaparib is a type of treatment known as a PARP inhibitor, which also targets the same kind of genetic weakness. The study will gradually increase the dose of MOMA-313 in small groups of patients to carefully find the safest and most effective dose. The information collected from this study – about safety, how the body handles the drug, and any signs of its effectiveness – will help guide future research into MOMA-313.

Key takeaways

  • It's an early-stage (Phase 1) study for advanced solid tumours.
  • Investigates a new drug, MOMA-313, taken by mouth.
  • Focuses on tumours with a specific genetic weakness (HR-deficient).
  • Aims to find a safe dose and look for early signs of effectiveness.
  • MOMA-313 may be given alone or with Olaparib.
  • Participation involves regular check-ups and monitoring for safety and response.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have a confirmed diagnosis of certain advanced solid tumours that cannot be cured by current standard treatments. Specifically, your tumour must show a particular genetic weakness called 'homologous recombination deficiency' (HR-deficient).

If you are considered for MOMA-313 on its own, your tumour needs to be HR-deficient. If you are considered for MOMA-313 combined with Olaparib, your tumour also needs to be HR-deficient, and you might have been treated with a PARP inhibitor before or be new to this type of treatment, depending on which part of the study you join. You must also be well enough to take part, meaning you can look after yourself and have healthy enough organ function.

There are also reasons why you might not be able to join. For example, if you have another active cancer, significant heart problems, uncontrolled spread of cancer to the brain, signs of an active infection, or if you have previously taken a similar drug to MOMA-313. Women who are pregnant or breastfeeding cannot participate. Your doctors will review your full medical history to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have an advanced solid tumour diagnosis (e.g., prostate, breast, pancreas)?
  3. Does your tumour have a specific genetic weakness (homologous recombination deficiency)?
  4. Are you able to take medication by mouth?
  5. Are you generally well enough to participate in a clinical trial?
  6. Are you not currently pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo a thorough check-up to make sure you meet all the criteria. This will involve examinations, blood tests, and scans. You will receive MOMA-313 as an oral medication (a pill). Depending on which group you are in, you might also take Olaparib pills.

Throughout the study, you will have regular clinic visits. During these visits, doctors will monitor your health closely, check for any side effects, take blood and other samples, and perform scans to see how your cancer is responding. The number of visits and the assessments will be more frequent at the beginning of the treatment to carefully monitor the new drug. Initially, doses of MOMA-313 will be slowly increased in small groups of patients until the safest and most effective dose is found. After treatment, there will be a follow-up period to continue monitoring your health and any long-term effects. The total length of your participation will depend on how you respond to the treatment and the study's design, but typically involves active treatment followed by a period of observation.

Potential risks and benefits

As with any clinical trial, there are potential benefits and risks to consider. A potential benefit of taking part is that you might receive a new treatment that is not yet widely available and could potentially help to control your cancer. You would also be contributing valuable information that could help others with cancer in the future. However, there is no guarantee that MOMA-313 will be effective for your cancer, and it may not improve your condition. There could be side effects from MOMA-313, or from the combination of MOMA-313 and Olaparib, which can range from mild to severe, some of which may be currently unknown. All potential known risks will be fully explained to you before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Investigative Site #108
    Verified postcode
    Goodyear, United States
  • Investigative Site #101
    Verified postcode
    La Jolla, United States
  • Investigative Site #111
    Verified postcode
    San Francisco, United States
  • Investigative Site #104
    Verified postcode
    Lake Mary, United States
  • Investigative Site #110
    Verified postcode
    St Louis, United States
  • Investigative Site #103
    Verified postcode
    New York, United States
  • Investigative Site #106
    Verified postcode
    New York, United States
  • Investigative Site #109
    Verified postcode
    Philadelphia, United States
  • Investigative Site #107
    Verified postcode
    Myrtle Beach, United States
  • Investigative Site #102
    Verified postcode
    Nashville, United States
  • Investigative Site #105
    Verified postcode
    San Antonio, United States
  • Investigative Site #112
    Verified postcode
    Fairfax, United States

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours, such as prostate, breast, or pancreatic cancer, that have a specific genetic weakness called 'homologous recombination deficiency'.

What does MOMA-313 do?

MOMA-313 is a new drug designed to target the specific genetic weakness in these cancers, aiming to stop cancer cells from repairing themselves and growing.

Will I receive MOMA-313 alone or with another drug?

You might receive MOMA-313 on its own or in combination with another established cancer drug called Olaparib, depending on the study group you are in.

What is the aim of this 'Phase 1' study?

The main aim of this early-stage study is to find out if MOMA-313 is safe, what the best dose is, and how your body handles it. Researchers will also look for early signs of whether it could help treat cancer.

Can I stop participating in the study at any time?

Yes, you are free to withdraw from the study at any point, for any reason, without it affecting your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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