RWF_RPL-001-16

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Inclusion Criteria:
• Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
• Have at least one injectable tumor
For Subjects in the Combination Treatment
• Baseline ECG that does not show abnormalities according to the protocol
• Baseline oxygen saturation levels that do not show abnormalities according to the protocol
• Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
For Subjects in Phase 2 only
• Have a predicted life expectancy of ≥ 3 months
• Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria,
• Subjects with melanoma: has Stage IIIb to IV (skin, eye or mucosal) for whom anti PD-1 therapy is indicated or who have previously received an anti-PD-1 therapy, or have refused, become intolerant to or have no further therapy options available
• Subjects with MSI-H tumors: has diagnosis of MSI-H tumor (according to protocol definition) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
• Subject with dMMR tumors: has diagnosis of dMMR tumor (according to protocol definition) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
• Subject with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available Subjects with bladder cancer: diagnosis of locally advanced or metastatic bladder cancer for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available

Exclusion Criteria:
• Prior treatment with an oncolytic therapy
• History of viral infections according to the protocol
• Systemic infection requiring IV antibiotics within 14 days prior to dosing
• Prior complications with herpes infections
• Chronic use of anti-virals
• Systemic therapies for cancer within 4 weeks of first dose (some others may be accepted with shorter time periods)
• Known active brain metastases - previously treated brain metastases may be permitted
• Prior certain other diagnosis of cancer
• Is participating in another clinical study or has participated in the past 4 weeks prior to the first dose
Combination Phase Subjects
• Certain autoimmune diseases, some types will be permitted
• Allergy or sensitivity to study drug components
• History of interstitial lung disease
• History of non-infectious pnuemonitis
• Other serious or uncontrolled medical disorders
Phase I/II
NCT03767348
Oncology
Multiple Tumor Types
Brendan Curti, M.D.
Replimune Inc.
Melissa Pomeroy
  • Providence Cancer Institute Franz Clinic