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

NCT02653313 | Completed Phase 1 DMC

• 1 other identifier: ParvOryx02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Pancreatic Ductal

Outcome Measures

Primary Outcomes (10)

• Safety and tolerability of the IMP

  Parameter: findings in physical examinations

  Up to 6 months after treatment beginning

• Safety and tolerability of the IMP

  Parameters: chosen laboratory parameters

  Up to 6 months after treatment beginning

• Safety and tolerability of the IMP

  Parameter: ECG

  Up to 6 months after treatment beginning

• Safety and tolerability of the IMP

  Parameter: adverse events

  Up to 6 months after treatment beginning

• Humoral immuneresponse to the IMP

  Parameter: Serum concentration of anti-drug antibodies (ADA)

  Up to 6 months after treatment beginning

• Pharmacokinetics of viral genomes [Vg]

  Parameter: Cmax in blood

  Up to 6 months after treatment beginning

• Pharmacokinetics of viral genomes [Vg]

  Parameter: AUC in blood

  Up to 6 months after treatment beginning

• Shedding of viral genomes [Vg]

  Parameter: Concentration of Vg in feaces

  Up to 6 months after treatment beginning

• Shedding of viral genomes [Vg]

  Parameter: Concentration of Vg in urine

  Up to 6 months after treatment beginning

• Shedding of viral genomes [Vg]

  Parameter: Concentration of Vg in saliva

  Up to 6 months after treatment beginning

Secondary Outcomes (9)

• Histo-immuno-pathological effects of the IMP in the hepatic metastasis

  Up to 2 months after treatment beginning

• Histo-immuno-pathological effects of the IMP in the hepatic metastasis

  Up to 2 months after treatment beginning

• Histo-immuno-pathological effects of the IMP in the hepatic metastasis

  Up to 2 months after treatment beginning

• Histo-immuno-pathological effects of the IMP in the hepatic metastasis

  Up to 2 months after treatment beginning

• Extent of virus replication in the hepatic metastasis

  Up to 2 months after treatment beginning

Study Arms (1)

ParvOryx

EXPERIMENTAL

ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).

Drug: Parvovirus H-1 (H-1PV)

Interventions

Parvovirus H-1 (H-1PV) DRUG

Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer. The total dose levels are: 1E09, 5E09 and 1E10 pfu.

Also known as: ParvOryx

ParvOryx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Eligibility for surgical treatment,
• Symptomatic cerebral, pulmonal, and/or osseous metastases,
• Peritoneal carcinosis,
• Liver cirrhosis,
• Splenectomy,
• 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),
• Positive anti-drug antibodies (ADAs) against ParvOryx,
• Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,
• Chemotherapy within 2 weeks prior to the first administration of the IMP,
• Contraindications for CT,
• Known allergy to iodinated contrast media,
• Participation in another interventional trial within the last 30 days,
• Presumed contact with pregnant women and/or infants \<12 months of age within two months after the first administration of the IMP.

Sponsors & Collaborators

• Oryx GmbH & Co. KG: lead

Study Sites (1)

National Center for Tumor Diseases (NCT)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (2)

• Hajda J, Lehmann M, Krebs O, Kieser M, Geletneky K, Jager D, Dahm M, Huber B, Schoning T, Sedlaczek O, Stenzinger A, Halama N, Daniel V, Leuchs B, Angelova A, Rommelaere J, Engeland CE, Springfeld C, Ungerechts G. A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. BMC Cancer. 2017 Aug 29;17(1):576. doi: 10.1186/s12885-017-3604-y.

  PMID: 28851316 BACKGROUND

• Hajda J, Leuchs B, Angelova AL, Frehtman V, Rommelaere J, Mertens M, Pilz M, Kieser M, Krebs O, Dahm M, Huber B, Engeland CE, Mavratzas A, Hohmann N, Schreiber J, Jager D, Halama N, Sedlaczek O, Gaida MM, Daniel V, Springfeld C, Ungerechts G. Phase 2 Trial of Oncolytic H-1 Parvovirus Therapy Shows Safety and Signs of Immune System Activation in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2021 Oct 15;27(20):5546-5556. doi: 10.1158/1078-0432.CCR-21-1020. Epub 2021 Aug 23.

  PMID: 34426438 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Bernard Huber, Dr.

  Oryx GmbH & Co. KG

  STUDY DIRECTOR

• Guy Ungerechts, Prof. Dr. Dr.

  National Center for Tumor Diseases, Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: January 12, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 21, 2022

Record last verified: 2019-03

Locations

DE (1)