Recruiting

Study of AZD3470 alone and in combination with other cancer drugs for patients with advanced solid tumors that are MTAP deficient

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

This study focuses on patients with advanced solid tumors that have a specific characteristic called MTAP deficiency (a missing or non-functioning protein in cancer cells). The main treatment being tested is AZD3470, a new drug that targets a specific protein involved in cancer growth. Some patients may also receive this drug in combination with other anti-cancer treatments.

The study aims to determine if AZD3470 is safe to use and to find the right dose for future treatment. During the study, patients will receive either AZD3470 alone or combined with other cancer medications. In the United States, some patients will also receive midazolam and dextromethorphan to understand how AZD3470 interacts with these common medications.

Throughout the study, doctors will monitor patients for any side effects and check if the treatment is working by performing regular medical examinations and scans. They will also measure how the drug moves through the body and track changes in tumor size. The study involves taking the medication by mouth in the form of film-coated tablets.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
The trial begins with confirming your eligibility through MTAP deficiency testing of your tumor tissue sample.
Your overall health status will be evaluated using the ECOG performance scale, which must be 0 or 1, indicating you can perform most daily activities.
Your tumor will be measured to establish a baseline using RECIST criteria, which is a standardized way to measure tumors.
Step 2
Treatment phase - Module 1, Part A
You will receive AZD3470 in the form of film-coated tablets for oral use.
During the dose escalation phase, the amount of medication may be adjusted based on how your body responds.
For U.S. participants only: You may receive additional oral medications: Midazolam (oral solution) and Dextromethorphan (syrup) to study how these drugs interact with AZD3470.
Step 3
Monitoring and assessments
Regular checks will be performed to monitor any side effects of the treatment.
Your tumor will be measured regularly to track any changes in size.
Blood samples will be taken to measure drug levels in your body.
If you are in the U.S., additional blood samples will be taken to measure how AZD3470 interacts with other medications.
Step 4
Follow-up period
Your health status will continue to be monitored after completing the treatment.
The study will track how long the treatment effects last.
The total duration of the study is planned from March 2024 to February 2026.

Who can join the trial?

10 criteria

Must be at least 18 years old to provide legal consent for participation
Must be willing to provide tumor tissue samples for testing of MTAP deficiency (a specific genetic change in tumor cells)
Must have previously received standard treatment for their specific type of cancer and either did not respond well to it or could not tolerate it
Must have had at least one previous treatment for cancer that has spread (metastatic) or returned (recurrent)
Must have confirmed MTAP deficient tumors, shown by specific genetic testing of tumor tissue
Must have a good level of physical function, scoring 0-1 on the ECOG scale (a measure of daily living abilities)
Must have an expected survival of at least 12 weeks, as determined by the doctor
Must have at least one tumor that can be measured using standard imaging techniques (RECIST criteria)
Must have adequate function of major organs and bone marrow
Must use appropriate contraception methods during the study, following local regulations

Who cannot join the trial?

14 criteria

History of other malignant tumors (cancers) in the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer
Current participation in other clinical trials or use of investigational drugs within 28 days before starting this study
Presence of active brain metastases (cancer spread to the brain) or spinal cord compression
Significant heart conditions including:
- Heart failure with symptoms
- Unstable heart rhythm problems
- Heart attack in the past 6 months
- Severe liver problems or abnormal liver function tests
- Severe kidney problems or abnormal kidney function tests
- Active, uncontrolled infections requiring treatment
- Known positive test for HIV, hepatitis B, or hepatitis C
- Pregnancy or breastfeeding
- Unable to swallow oral medications
- Any medical condition that, in the investigator's opinion, would make participation unsafe
- Known allergies or severe reactions to similar medications

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Verified sites

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

Hospital Universitario De Navarra
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Pamplona, Spain
Hospital Vall d’Hebron
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Barcelona, Spain
Institut Gustave Roussy
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Villejuif, France

Trial locations

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Investigated drugs

AZD3470 is an experimental medication designed to target specific proteins in cancer cells that lack a particular enzyme called MTAP. It works by inhibiting PRMT5, which is a protein that helps cancer cells grow. This medication is being tested both alone and in combination with other cancer treatments to see if it can help patients with advanced solid tumors. The trial also includes unspecified anti-cancer agents that will be combined with AZD3470, but their specific names are not provided in the source data.

What is already known about the treatment

AZD3470 – A novel PRMT5 inhibitor medication being investigated in clinical trials for the treatment of advanced or metastatic solid tumors that are MTAP deficient. The drug works by targeting and inhibiting the PRMT5 enzyme in a cooperative manner with MTA, which is particularly effective in cancers lacking MTAP expression. Currently undergoing Phase I/IIa clinical trials as both monotherapy and in combination with other anti-cancer agents, this investigational drug is administered to assess its safety profile, tolerability, and to determine the recommended Phase 2 dose (RP2D) in cancer patients. The medication represents a targeted therapeutic approach in oncology, specifically designed for patients whose tumors exhibit MTAP deficiency.

Investigated diseases

Advanced/Metastatic Solid Tumors with MTAP Deficiency - A condition where cancer cells have spread from their original location to other parts of the body (metastasis) and are characterized by a specific genetic alteration called MTAP deficiency. This type of cancer begins as a solid mass in organs or tissues and can affect various parts of the body. MTAP deficiency refers to the loss or reduced function of the MTAP gene, which plays a role in cellular metabolism. The condition typically develops from an initial tumor that grows and eventually spreads to distant sites in the body through the bloodstream or lymphatic system. The cancer cells in this condition have specific molecular characteristics that distinguish them from other types of cancer cells.