A first in man study of RGT100 injection into solid tumors

Phase 1

• Conditions: 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 Classification code 10024717 Term: Liver tumor System Organ Class: 100000020895; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003028-22-GB
• Lead Sponsor: Rigontec GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-28
• Study Completion: 2018-05-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

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 < 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)/RECIL for lymphomas 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: 0
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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified