Purpose of this Study
We are doing this study to find out if an experimental drug called IMM-1-104 (the study drug) is a safe and effective option for patients with melanoma, pancreatic cancer, or lung cancer. We also want to find out what dose of the study drug works best.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with one of the following cancers: melanoma, pancreatic cancer, or lung cancer</li>
<li>Have documented RAS-mutated advanced or metastatic solid tumor(s)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: annemarie.peters@duke.edu">annemarie.peters@duke.edu.</a>
<li>Are diagnosed with one of the following cancers: melanoma, pancreatic cancer, or lung cancer</li>
<li>Have documented RAS-mutated advanced or metastatic solid tumor(s)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: annemarie.peters@duke.edu">annemarie.peters@duke.edu.</a>
What is Involved?
If you choose to join the study, you will go through a screening period to find out if you are eligible. During this period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor</li>
<li>Have imaging (CT scan or MRI)</li></ul>
If you are eligible to continue in the study after screening, you will proceed to the dosing period. During this period, you will take the study drug in timeframes called cycles. Each cycle lasts 28 days.
You will take the study drug by mouth every day at the same time for each day of the cycle. During the first cycle, you will visit our clinic several times. For every cycle after the first one, you will only need to visit our clinic on the 1st and 15th days of each cycle.
You will take the study drug for up to 12 cycles during this study. The study doctor might stop your use of the study drug before then if they believe that you are not benefiting from it.
You will visit our clinic for follow-up visits one week and one month after you stop taking the study drug. We will keep in touch with you for about a year after you finish the study to see how you are doing.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor</li>
<li>Have imaging (CT scan or MRI)</li></ul>
If you are eligible to continue in the study after screening, you will proceed to the dosing period. During this period, you will take the study drug in timeframes called cycles. Each cycle lasts 28 days.
You will take the study drug by mouth every day at the same time for each day of the cycle. During the first cycle, you will visit our clinic several times. For every cycle after the first one, you will only need to visit our clinic on the 1st and 15th days of each cycle.
You will take the study drug for up to 12 cycles during this study. The study doctor might stop your use of the study drug before then if they believe that you are not benefiting from it.
You will visit our clinic for follow-up visits one week and one month after you stop taking the study drug. We will keep in touch with you for about a year after you finish the study to see how you are doing.
Study Details
Full Title
A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants with Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors (PO805)
Principal Investigator
Jeffrey
Clarke
Protocol Number
PRO00114623
NCT ID
NCT05585320
Phase
I/II
Enrollment Status
Open to Enrollment