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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.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03767348
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Inclusion Criteria:
Male or female ≥ 18 years of age on the day of signed informed consent
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
Exclusion Criteria:
Prior treatment with an oncolytic therapy
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.
Cancer
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Location
Hershey, PA