This is a Phase 1, open-label, dose-escalation and dose-expansion study comprised of a screening period, a single treatment session, an evaluation period of 21±3 days, and safety and survival follow-up period of up to 12 weeks post-treatment.
The purpose of this Phase 1 study is to initiate clinical development of gNO in patients with unresectable cutaneous or subcutaneous primary or metastatic solid tumors that are not amenable or have failed standard treatment, for which no therapy of proven efficacy exists, or which has progressed despite standard therapy. This study of gNO treatment will consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of gNO in patients with primary or metastatic unresectable cutaneous or subcutaneous solid tumors (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) and/or optimal biological dose (OBD) (or recommended Phase 2 dose \[RP2D\]) has been determined in the dose-escalation phase (Part A). This study will be the basis for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Intratumoral injection of 25,000 gNO
Intratumoral injection of 50000 gNO
Intratumoral injection of 100,000 gNO
Soroka Medical Center
Beersheba, Israel
RECRUITINGHadassah Ein-Karem
Jerusalem, Israel
RECRUITINGSheba Medical Center
Ramat Ef‘al, Israel
RECRUITINGIncidence of AEs, SAEs and DLTs (safety) parameters.
The incidence and characteristics of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs) and changes in assessed safety parameters. Toxicity will be graded according to NCI CTCAE version 5.0
Time frame: up to12 weeks from injection
Anti-tumor activity of a single intratumoral gNO injection at all administered doses
The anti-tumor activity of a single intratumoral gNO injection will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and secondarily immune-related RECIST (iRECIST).
Time frame: up to Day 21 from injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intratumoral injection of selected does on gNO
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel
RECRUITING