Solid tumors

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

Initial Screening	Up to 28 days
Treatment Period	About 2 months
Follow-up Period	About 4 months after the last dose of study drug

Part 2 – RP3 and anti-PD1 therapy

Initial Screening	Up to 28 days
Treatment Period	About 2 years
Follow-up Period	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..

This study is for patients with advanced 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. Patients will be placed in either a dose escalation or dose expansion group. The first part of the study explores appropriate doses to give to patients, while the second part uses the RP2 dose identified in part 1 and combines with nivolumab. Please note that part 1 (dose escalation) is complete. Every patient going forward will be given RP2 and nivolumab in combination.

Part 1 (Completed): In part 1, different doses of RP2 were given to patients once every 2 weeks. This study let the researchers determine the best dose of RP2 to be used in the second part of the study.

Part 2 (Ongoing): In the second part of the study, patients will receive RP2 in combination with another drug, nivolumab, every 2 weeks for about 3.5 months, then nivolumab would be given every 4 weeks for up to an additional 20 months. Patients may also receive up to 8 extra doses of RP2 in combination with nivolumab 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 RP2 is safe to give with nivolumab.

The study has different sections. They are:

Part 1 – RP2 Alone

Initial Screening	Up to 28 days
Treatment Period	Approximately 2 months
Follow-up Period	About 4 months after the last dose of study drug

Part 2 – RP2 and nivolumab

Initial Screening	Up to 28 days
Treatment Period	Approximately 2 years
Follow-up Period	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.

This study is currently in Phase 2 and is for patients with a diagnosis of Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Are capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form.
• Are at least 18 years old.
• Have at least 1 measurable tumor of ≥1 cm in longest diameter (or ≥1.5 cm shortest diameter for lymph nodes) and injectable lesions which in aggregate comprise ≥ 1 cm in longest diameter.
• Have a life expectancy of at least 3 months.
• Have not received prior treatment with an oncolytic virus therapy.
• Have no acute or chronic active hepatitis B and C virus infection, nor known history of hepatitis B, nor known active hepatitis C virus, nor HIV infection.
• Have no systemic infection requiring intravenous (IV) antibiotics nor other serious infection within 14 days prior to dosing.
• Have no history of interstitial lung disease.

What to expect during the study

The Phase 2 portion of this study is still enrolling the following two cohorts:
• Anti-PD-1 failed NMSC
• MSI-H or dMMR

Dosing of RP1 will start on Day 1 and will be administered every two weeks for up to eight cycles (approximately 4 months). After the first dose of RP1, dosing will be given with concurrent nivolumab infusion every two weeks followed by dosing every four weeks for up to an additional twenty months.

Patients may also receive additional courses of RP1 if they meet the protocol specified criteria for RP1 dose re-initiation.

The Phase 2 portion of study has different sections. They are:

Screening	Up to 28 days
Treatment Period	Approximately 2 years
Follow-up Period	3 years from last patient enrolled

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.