A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Cancers with KRAS G12D Mutation

Trial ID: NCT05382559

A study to assess the safety, tolerability and effectiveness of ASP3082 in participants with Solid Tumor Cancers that have a KRAS G12D Mutation

Trial Details

ASP3082 is a potential new treatment for people with certain solid tumor cancers. (A solid tumor is an abnormal mass of tissue in solid organs of the body.) In this study ASP3082 will be given through a vein. This is called an intravenous (IV) infusion. Before ASP3082 is available as a treatment for people with certain solid tumor cancers, researchers need to understand how this study drug is processed by the body and affects the body and whether a participant’s cancer responds to treatment with the study drug. This information, learned from this research study, will help find a suitable dose and check for potential side effects from the study drug.

The main goals of this study are to learn:

about the safety of the study drug
about how the body tolerates the study drug
about appropriate dosing of the study drug

This study will be conducted in 2 parts:

Part 1
- Small groups of people will receive lower to higher doses of ASP3082. Any side effects will be recorded at each dose. This is done to find suitable doses to use in Part 2 of the study.
- The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose. The panel will do this for each group until all groups have taken the study drug or until suitable doses have been selected for Part 2.
Part 2
- Different small groups of people will receive ASP3082 with the most suitable doses identified from Part 1. This will help find a more appropriate dose to use in future studies.

Estimated Enrollment

136 Participants

Phase

1

Eligibility Criteria

Participants must:

Adults in the U.S.
Have a cancer diagnosis other than blood cancer
Have been previously treated for your cancer
Have changes in KRAS G12D genetic biomarker

Participants must not:

Have received prior treatment with a specific KRAS G12D inhibitor.
Recently taken or is currently taking any other investigational study drug

Site Locations

You will need to travel to one of the study clinics taking part in this clinical trial.

What Will Happen In This Study

You will receive ASP3082 through IV infusion in a 21-day cycle.

You will continue study drug until:

you have side effects from the study drug
your cancer gets worse
you start other cancer treatment
you ask to stop study drug
you do not come back for study drug.

Clinic visits are required on certain days during your treatment, with extra visits during the first 2 cycles of treatment. During these visits, the study doctors will check for any side effects from ASP3082. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, breathing rate, and blood pressure. Also, blood and urine samples will be taken. Tumor samples will be taken during certain visits during treatment and when treatment has finished.

A visit to the clinic is also required within 7 days after stopping treatment. During this visit, the study doctors will check for any side effects from ASP3082. Other checks will include a medical examination, laboratory tests and vital signs.

Then, you may visit the clinic at 30 days and 90 days after stopping treatment.

At the 30-day visit, the study doctors will check for any side effects. You will have vital signs checked and have some laboratory tests.
At the 90-day visit, the study doctors will check for any side effects and you will have vital signs checked.

After this, clinic visits are required every 9 weeks. This is to check the condition of your cancer. You will do this until 45 weeks after treatment stopped, your cancer is worse, you start other cancer treatment, you ask to stop treatment, or you do not come back for treatment.

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

No, you will not be paid for your time. You may be reimbursed for: reasonable travel expenses for all required study visits to the hospital or clinic, and reasonable meal cost and hotel accommodations for specific visit. All study related services are provided at no cost.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new vaccines or treatments. A research plan or protocol is created that outlines how you may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Yes. You can leave a clinical trial, at any time. When withdrawing from the trial, you should let the research team know about it.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, sex, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

You have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue you at any time for the your safety, or if you no longer meets the study requirements.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.

Where can I find more information about solid tumor cancers and KRAS?

Here are some resources where you can search for more information: https://www.kraskickers.org/

This trial is not actively recruiting.