A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects with Advanced or Recurrent Tumors - A Phase I/II trial of intralesional administration of RGT100

Rigontec GmbH0 sites15 target enrollmentSeptember 28, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2016

End Date

May 18, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Male or female aged \= 18 years
•2\. Subjects with histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including all lymphomas except of NK\-cell origin) for whom all available standard treatments have been administrated or are not feasible and RGT100\-PEI is suitable treatment and option;
•a. For Group A: has cutaneous, subcutaneous, or lymph node injectable tumors
•b. For Group B: has injectable liver tumors or liver metastases
•3\. Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
•4\. Life expectancy \> 3 months as assessed by the Investigator
•5\. Adequate organ function:
•a. Bone marrow function: Hemoglobin \= 8\.5 g/dL (equal to 5\.28 mmol/L); lymphocyte count \= 0\.5 × 109/L; absolute neutrophil count \= 1\.0 × 109/L; platelet count \= 75 × 109/L
•b. Hepatic function: aspartate transaminase (AST) and alanine transaminase (ALT) \= 2 × upper limit of normal (ULN) (3 × ULN in the case of liver metastases); bilirubin \= 1\.5 × ULN (2 × ULN in case of liver metastases)
•c. Renal function: creatinine \< 1\.5 × ULN and/or creatinine clearance \= 50 mL/min (Cockroft and Gault)

•1\. Any tumor\-directed therapy within 21 days before study treatment
•2\. Treatment with investigational drugs within 21 days before study treatment
•3\. Systemic steroids at a daily dose of \> 10 mg of prednisolone, \> 2 mg of dexamethasone or equivalent, except non\-systemic (inhaled, topical, nasal) for the last 28 days and ongoing
•4\. Subjects with rapidly progressing disease (as determined by the Investigator)
•5\. Ongoing immune\-related adverse events (irAEs) and/or AEs \= grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
•6\. Within 4 weeks of major surgery
•7\. Prior splenectomy
•8\. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy
•9\. Primary or secondary immune deficiency
•10\. Active allergy requiring systemic medication or active infections requiring anti\-infectious therapy