RP3-301 – A Study Evaluating RP3 Given Alone and in Combination with Anti-PD1 Therapy in Patients with Solid Tumors
Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04735978
This is a Phase 1 clinical trial to study the investigational oncolytic immunotherapy RP3 given both alone and in combination with anti-PD1 therapy. Researchers will study the safety of this treatment in these patients and also evaluate its ability to shrink tumors.
Who is this study for?
This study is for patients with advanced or metastatic solid tumors.
Key eligibility criteria
You may be eligible for this study if you meet the following conditions:
• Have a non-neurological solid tumor
• Have had your cancer progress on standard therapy or could not tolerate the side effects of standard therapy
• Are at least 18 years old
• Have not been treated with a prior oncolytic immunotherapy
Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.
What to expect during the study
This study has 2 parts, dose escalation and dose expansion. The first part of the study (dose escalation) explores appropriate doses to give to patients, while the second part (dose expansion) uses the RP3 dose identified in part 1 and combines with an anti-PD1 therapy.
Part 1: In part 1, different doses of RP3 will be given to patients once every 2 weeks. This part of the study will let the researchers look at the safety of the drug while determining the best dose of RP3 to be used in the second part of the study. Patients may also receive up to 8 extra doses of RP3 within 12 months of starting the study.
Part 2: In the second part of the study, patients will receive RP3 in combination with anti-PD1 therapy every 2 weeks for about 4 months, then anti-PD1 therapy would be given every 4 weeks for up to an additional 20 months. Patients may also receive up to 8 extra doses of RP3 in combination with anti-PD1 therapy if the treatment helps to further shrink the tumor within 20 months. Researchers will look at the safety of the drugs and whether the tumors shrink. This will let the researchers determine whether RP3 is safe to give with anti-PD1 therapy.
Researchers will look at the safety of the drugs and whether the tumor(s) shrink. This will let the researchers determine whether RP3 is safe to give either alone or with anti-PD1 therapy and whether the drug(s) could be effective in treating your type of cancer.
The study has different sections. They are:
Part 1 – RP3 Alone
|Up to 28 days
|About 2 months
|About 4 months after the last dose of study drug
Part 2 – RP3 and anti-PD1 therapy
|Up to 28 days
|About 2 years
|About 3 months after the last dose of study drug
IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled..