Advanced or recurrent tumors MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000020962 MedDRA version: 20.0 Level: LLT Classification code 10024700 Term: Liver metastases System Organ Class: 100000020848 MedDRA version: 20.0 Level: LLT
Conditions
Sponsors
Rigontec GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 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 11. Seropositive (except after vaccination) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) 12. Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry 13. Dementia or altered mental status that would prohibit informed consent 14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator 15. History of stroke (within 6 months prior to study entry), seizures (within 6 months prior to study entry), encephalitis, or multiple sclerosis 16. Gastric ulcer or inflammatory bowel disease or Crohn’s disease or ulcerative colitis in the last 6 months. 17. Active drug or alcohol abuse 18. Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the safety and tolerability of intratumoral/intralesional injections of RGT100-PEI • Determine the recommended Phase 2 dose feasible for intratumoral/intralesional injections of RGT100-PEI ; Secondary Objective: - Explore preliminary anti-tumor activity of RGT100-PEI on injected and un-injected tumor lesions The exploratory objectives: - Investigate the type of cytokine release in plasma upon treatment - Investigate the pharmacokinetics (PK) of RGT100-PEI in subjects with advanced or recurrent tumors ; Primary end point(s): • Incidence and severity of treatment-related adverse events (AEs) and laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE) v.4.03 criteria • Occurrence of serious adverse events (SAEs) • Occurrence of treatment discontinuation due to treatment-related AEs • Incidence and severity of dose limiting toxicities (DLTs) ;Timepoint(s) of evaluation of this end point: after dose escalation and at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective response rate as evaluated radiologically using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)/RECIL for Lymphoma. The exploratory endpoints of the study are: • Type of cytokine release in plasma • Plasma concentrations of RGT100-PEI and, where feasible, standard PK parameters Exploratory end points: • Type of cytokine release in plasma • Plasma concentrations of RGT100-PEI and, where feasible, standard PK parameters • Presence of predictive biomarkers of tumor responses* • Evidence of immune infiltration of injected tumors* ; Timepoint(s) of evaluation of this end point: The secondary objectives will be evaluated at the end of the trial The exploratory objectives will be evaluated in a separate sub-study | — |
Countries
France, Germany, Spain, United Kingdom
Contacts
Public ContactDr. Manuela Niewel
Rigontec GmbH
Outcome results
None listed