Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2016-003028-22-ES
EUCTR2016-003028-22-ESActive, not recruitingPhase 1

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 enrollmentStarted: October 26, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
15
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Male or female aged = 18 years
  • •2. Histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom RGT100-PEI is a suitable treatment option and:
  • •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 = 10 g/dL (pre-treatment transfusion allowed); lymphocyte count = 0.5 × 109/L; absolute neutrophil count = 0.5 × 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)
  • •6. Negative serum pregnancy test within 2 weeks before first dose of study drug if the subject is a woman of childbearing potential. Subjects and subjects’ partners of childbearing potential must agree to use birth control consistently and correctly during the study and for at least 6 months after the last study drug application.
  • •7. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and 1 separate injectable lesion with diameter = 1 cm but < 7 cm
  • •8. Ability to provide written informed consent before any study drug-related screening procedures being performed
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 74
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

  • •1. Any tumor-directed therapy within 4 weeks before study treatment
  • •2. Treatment with investigational drugs within 4 weeks before study enrolment
  • •3. Systemic steroids at a dose of > 10 mg of prednisolone, > 2 mg of dexamethasone a day or equivalent, except topical (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, seizures, 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

Investigators

Similar Trials

Active, not recruiting
Phase 1
A first in man study of RGT100 injection into solid tumors
EUCTR2016-003028-22-DERigontec GmbH15
Active, not recruiting
Phase 1
A first in man study of RGT100 injection into solid tumorsAdvanced or recurrent tumorsMedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000020962MedDRA version: 20.0 Level: LLT Classification code 10024700 Term: Liver metastases System Organ Class: 100000020848MedDRA version: 20.0 Level: LLT Classification code 10024717 Term: Liver tumor System Organ Class: 100000020895
EUCTR2016-003028-22-FRRigontec GmbH15
Active, not recruiting
Phase 1
A first in man study of RGT100 injection into solid tumors
EUCTR2016-003028-22-GBRigontec GmbH15
Active, not recruiting
Phase 1
Study to identify an appropriate Modufolin® dose with respect to safety and ability to mitigate high-dose Methotrexate induced toxicity in osteosarcoma patients.
EUCTR2013-001280-23-HUIsofol Medical AB18
Active, not recruiting
Phase 1
Study to identify an appropriate Modufolin® dose with respect to safety and ability to mitigate high-dose Methotrexate induced toxicity in osteosarcoma patients.
EUCTR2013-001280-23-SEIsofol Medical AB18
A first in man study of RGT100 injection... | Clinical Trial