IGNYTE

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.

Klinische Settings

Indikation: Plattenepithelkarzinom

Einschlusskriterien

  • locally advanced or metastatic NMSC that are not considered treatable by surgery including
  • BCC, cSCC, basosquamous carcinoma, MCC and other NMSC for whom anti-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
  • ECOG 0-1
  • At least one measurable and injectable lesion
  • Tumor pathology available
  • Predicted life expectancy of ≥ 3 months
  • Measurable disease, according to Response Evaluation Criteria in
    Solid Tumors (RECIST) v1.1 criteria

Ausschlusskriterien

  • 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
  • Historyof interstitial lung disease
  • History of non-infectious pneumonitis
  • History of clinically significant cardiovascular disease

Links

An der Studie beteiligte Zentren

Berlin

Zentrum

Charité Berlin - Campus Benjamin Franklin
Early Clinical Trial Unit
Berlin

Kontakt

Herr Prof. Dr. Sebastian Ochsenreither sebastian.ochsenreither@charite.de

Essen

Zentrum

Hauttumorzentrum am Westdeutschen Tumorzentrum
Universitätsmedizin Essen
Hufelandstraße 55 45147 Essen Deutschland

hautklinik.uk-essen.de

Kontakt

Herr Prof. Dr. Dirk Schadendorf sekretariat.dermatologie@uk-essen.de

Kiel

Zentrum

Hautkrebszentrum Kiel
Klinik für Dermatologie, Venerologie und Allergologie
Universitätsklinikum Schleswig-Holstein Campus Kiel
Arnold-Heller-Straße 3 24105 Kiel Deutschland

www.uksh.de

Kontakt

Frau PD Dr. Katharina C. Kähler dermaambulanz@uksh.de

Marburg

Zentrum

Marburger Hauttumorzentrum
Klinik für Dermatologie, Venerologie und Allergologie
Universitätsklinikum Gießen und Marburg
Baldingerstraße 35043 Marburg Deutschland

www.ccc-marburg.de

Kontakt

Herr Dr. Martin Gschnell martin.gschnell@med.uni-marburg.de