Open Actively Recruiting

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
No
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

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Study Stats
Protocol No.
20-001186
Category
Hematology-Oncology
Oncology
Contact
Elizabeth Seja
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03767348
For detailed technical eligibility, visit ClinicalTrials.gov.