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Study on the Safety and Tolerability of D3S-001 Alone or with Drug Combination in Adults with Advanced Solid Tumors with KRAS p.G12C Mutation

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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 advanced solid tumors that have a specific genetic change known as the KRAS p.G12C mutation. The trial is testing a new treatment called D3S-001, which is a type of medicine known as a KRAS p.G12C mutant protein inhibitor. This medicine is being tested both on its own and in combination with other cancer treatments to see if it is safe and can be tolerated by patients. The other treatments being used in combination include Keytruda (also known as pembrolizumab), Erbitux (also known as cetuximab), carboplatin, cisplatin, and pemetrexed. These are all medicines that are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and tolerability of D3S-001 in people with advanced solid tumors that have the KRAS p.G12C mutation. The study will be conducted in different parts. In the first part, D3S-001 will be given alone to see how the body handles it and to determine the best dose. In the later parts, D3S-001 will be combined with other cancer treatments to see how well they work together. Participants will receive the treatment and be monitored for any side effects or changes in their health. The study will also look at how the medicine moves through the body and how it affects the tumors.

Throughout the study, participants will have regular check-ups, which may include physical exams, blood tests, and scans like MRI or CT (computed tomography) to monitor their health and the progress of the treatment. The study aims to find the most effective and safe dose of D3S-001 for future use in treating patients with this specific type of cancer mutation. The trial is expected to continue until 2027, with recruitment starting in 2024.

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
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the safety and tolerability of a new medication called D3S-001 for individuals with advanced solid tumors that have a specific genetic change known as KRAS p.G12C mutation.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of the KRAS p.G12C mutation and ensuring the patient has measurable disease according to specific criteria.
Step 3
Treatment phase 1
In the first phase of treatment, the patient will receive D3S-001 as a monotherapy. This involves taking the medication orally in the form of capsules. The dosage and frequency will be determined based on the patient's response and tolerance.
Step 4
Treatment phase 2
If the patient progresses to the second phase, the treatment may include a combination of D3S-001 with other medications such as pembrolizumab (Keytruda), cetuximab (Erbitux), carboplatin, cisplatin, or pemetrexed. These are administered through intravenous infusion, which means they are given directly into the bloodstream through a vein.
Step 5
Monitoring and follow-up
Throughout the trial, the patient's health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the response to treatment and any side effects. Adjustments to the treatment plan may be made based on these assessments.
Step 6
Completion of the trial
The trial is expected to continue until June 2027. Upon completion, the patient will undergo a final evaluation to determine the overall impact of the treatment on their condition.

Who can join the trial?

5 criteria

The patient must have a confirmed advanced solid tumor that is either spreading or growing.
The patient must have a documented KRAS p.G12C mutation. This is a specific change in the genes of the tumor, identified within the last 5 years through a test on tumor tissue or blood.
The patient must have a disease that can be measured using imaging tests like CT (computed tomography) or MRI (magnetic resonance imaging). This means there should be at least one tumor that can be accurately measured.
The patient must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must have adequate organ and bone marrow function, as determined by tests during the screening period.

Who cannot join the trial?

3 criteria

Patients who do not have advanced solid tumors with a KRAS p.G12C mutation cannot participate. This is a specific change in a gene that can affect how cancer grows.
Patients who are not adults cannot participate. This means the study is only for people who are 18 years or older.
Patients who are part of a vulnerable population cannot participate. This usually refers to groups of people who might need special protection or care.

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Verified sites

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Azienda Ospedaliera Universitaria Senese
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Siena, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
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Madrid, Spain
Haematologisch Onkologische Praxis Eppendorf
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Hamburg, Germany

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Investigated drugs

D3S-001 is an investigational medication being studied for its potential to treat advanced solid tumors that have a specific genetic mutation known as KRAS p.G12C. This medication is being tested to understand how safe and tolerable it is when used alone or in combination with other treatments. The study aims to find the most effective dose that patients can tolerate without significant side effects.

What is already known about the treatment

D3S-001 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors with a specific genetic mutation known as KRAS p.G12C. It is in the early stages of research, with ongoing studies to determine its optimal dosage and potential benefits. The main therapeutic indication for D3S-001 is targeting tumors with the KRAS p.G12C mutation, which is a common mutation in certain types of cancer. At the molecular level, D3S-001 works by inhibiting the activity of the mutated KRAS protein, which is involved in cell growth and division, thereby potentially slowing down or stopping the growth of cancer cells. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

Advanced Solid Tumors with a KRAS p.G12C Mutation – This condition involves a group of cancers that have spread beyond their original site and possess a specific genetic mutation known as KRAS p.G12C. These tumors can occur in various organs and are characterized by uncontrolled cell growth due to the mutation. The KRAS p.G12C mutation affects the KRAS protein, which plays a role in cell signaling pathways that control cell growth and division. As the disease progresses, the tumors may grow larger and potentially spread to other parts of the body. The presence of the KRAS p.G12C mutation can influence the behavior of the tumor and its response to certain therapies. Understanding the mutation is crucial for developing targeted treatments.