Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I/II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
At least one measurable and injectable lesion
Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
Have a predicted life expectancy of ≥ 3 months
Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic 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
Subjects 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-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
Subjects with anti-PD1 failed NSCLC: has confirmed progressive disease after no more than two prior systemic treatments including anti-PD1/PD-L1 treatment

Exclusion Criteria:

Prior treatment with an oncolytic therapy
History of viral infections according to the protocol
Prior complications with herpes infections
Chronic use of anti-virals
Uncontrolled/untreated brain metastasis
History of interstitial lung disease
History of non-infectious pneumonitis
History of clinically significant cardiovascular disease

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you