Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer

Phase 1

Completed

• Conditions: Carcinoma, Pancreatic Ductal
• Interventions: Drug: Parvovirus H-1 (H-1PV)

• Registration Number: NCT02653313
• Lead Sponsor: Oryx GmbH & Co. KG

Brief Summary

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Detailed Description

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Initially four equal doses of ParvOryx will be administered intravenously on four consecutive days. Seven to fourteen days after the first intravenous administration the drug will be injected directly in a hepatic metastasis of the pancreatic cancer.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-03
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Age at least 18 year,
2. Ability to give informed consent,
3. Histologically confirmed pancreatic ductal adenocarcinoma (PAD) with at least one measurable hepatic metastasis according to RECIST 1.1,
4. Disease progression despite first line therapy (whatever chemotherapy regimen),
5. Eligibility for second line chemotherapy with gemcitabine,
6. ECOG performance scale 0 or 1,
7. Consent for the sampling and investigations of biological specimens as scheduled by the trial protocol,
8. Adequate bone marrow function: neutrophils >1.5 x 1E09/L, platelets >100 x 1E09/L, hemoglobin >9.0 g/dL,
9. Liver function tests (LFT) within the following range: Bilirubin <3 x ULN (Upper Limit of Normal); ASAT and ALAT <5 x ULN,
10. Adequate renal function: Creatinine <1.5 g/dL,
11. Adequate blood clotting: aPTT <39 sec, INR <1.2,
12. Normal thyroid function, i.e. TSH, fT3 and fT4 within the normal range (TSH: 0.4 - 4.0 mU/l, fT3: 2.0 - 4.2 ng/l, fT4: 8 - 18 ng/l)
13. Negative serology for HIV, HBV and HCV,
14. Negative Beta-HCG test in blood in woman of childbearing potential,
15. Use of adequate contraception in both genders, i.e. use of double-effective method of contraception for the entire participation in the trial.

Exclusion Criteria

1. Eligibility for surgical treatment,
2. Symptomatic cerebral, pulmonal, and/or osseous metastases,
3. Peritoneal carcinosis,
4. Liver cirrhosis,
5. Splenectomy,
6. Relevant respiratory impairment, corresponding to the grade IV or V of the MRC Breathlessness Scale (stops for breath after walking about 100 meters or after a few minutes on level ground, or too breathless to leave the house, or breathless when undressing),
7. Positive anti-drug antibodies (ADAs) against ParvOryx,
8. Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,
9. Chemotherapy within 2 weeks prior to the first administration of the IMP,
10. Signs of active, systemic infection within 7 days prior to the study inclusion (clinical symptoms (cough, running nose, burning sensation while urinating, apparent skin or wound infection) and/or increase of fever and/or deterioration of infection-specific laboratory parameters beyond changes apparently driven by the underlying pancreatic cancer),
11. Radiotherapy within 6 weeks prior to the study inclusion,
12. Contraindications for CT,
13. Known allergy to iodinated contrast media,
14. Participation in another interventional trial within the last 30 days,
15. Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ParvOryx	Parvovirus H-1 (H-1PV)	ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).

Primary Outcome Measures

Name	Time	Method
Shedding of viral genomes [Vg]	Up to 6 months after treatment beginning	Parameter: Concentration of Vg in saliva
Safety and tolerability of the IMP	Up to 6 months after treatment beginning	Parameter: adverse events
Humoral immuneresponse to the IMP	Up to 6 months after treatment beginning	Parameter: Serum concentration of anti-drug antibodies (ADA)
Pharmacokinetics of viral genomes [Vg]	Up to 6 months after treatment beginning	Parameter: AUC in blood

Secondary Outcome Measures

Name	Time	Method
Histo-immuno-pathological effects of the IMP in the hepatic metastasis	Up to 2 months after treatment beginning	Parameter: tissue content of chemokines
Cellular immune response against viral proteins	Up to 6 months after treatment beginning	Parameter: FACS
Clinical outcome	Up to 6 months after treatment beginning	Parameter: Serum concentration of CA19-9
Extent of virus replication in the hepatic metastasis	Up to 2 months after treatment beginning	Parameters: quantification of NS-1 protein in the metastatic tissue

Trial Locations

Locations (1)

National Center for Tumor Diseases (NCT); 🇩🇪 Heidelberg, Baden-Württemberg, Germany