Site for An Open-Label, Multicenter, Phase I/II Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
This study is to determine the maximum tolerated dose (MTD) as determined by how often dose limiting toxicities (DLT) happen and/or the recommended Phase 2 dose of the study drug RP1.
A 28-day Screening period A Study Treatment period which will last up to 2 years. A Follow-Up period – 30 days after last RP1 injection and then 60 days after last RP1 treatment and then also 100 days after the last nivolumab treatment Long Term follow-up period – If you need to stop either the RP1 injections or nivolumab infusions, you will be asked to return at least every 12 weeks for a period of 2 years. You will also be asked about any other anti-cancer therapy you may be taking, every 3 months, for a period of 3 years, from the start of the RP1 injections.
, travel and lodging services may be provided
At least 1 measurable (including use of image-guided injection) tumor of ≥ 1 cm in longest diameter (or shortest diameter ≥ 1.5 cm for lymph nodes) and injectable lesions which in aggregate comprise ≥ 1 cm in longest diameter
Adequate hematologic function, adequate hepatic function, adequate renal function
Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 × ULN
ECOG performance status 0-1
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) or HIV infection.
Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing
Requires intermittent or chronic use of systemic (oral or IV) anti-virals with known anti-herpetic activity (e.g., acyclovir)
With a condition requiring systemic treatment with either corticosteroids (> 20 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment.