ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers

NCT01598129 | Completed Phase 1 Results DMC

• 1 other identifier: Oncos-C1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the safety and the recommended dose for later use of an oncolytic adenovirus CGTG-102 in combination with low-dose oral cyclophosphamide in the treatment of advanced cancers.

Conditions

Malignant Solid Tumour

Keywords

Phase I; Dose escalation; oncolytic virus

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.

  6 months

• Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities

  No Dose Limiting Toxicities were observed at any dose level.

  6 months

Secondary Outcomes (1)

• To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.

  12 months

Other Outcomes (5)

• Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.

  3 months

• Quality of Life Using EORTC QLQ-C30.

  12 months

• An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.

  6 hours

Study Arms (1)

CGTG-102

EXPERIMENTAL

CGTG-102 dose escalation

Genetic: ONCOS-102

Interventions

ONCOS-102 GENETIC

GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

CGTG-102

Eligibility Criteria

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

You may qualify if:

• Solid tumour refractory to evidence-based oncological therapies.
• Age 18 years and over.
• At least one tumour mass measurable by PET (i.e. PET-positive lesion that can reliably be assessed for SUVmax, typically featuring longest diameter ≥2 cm).
• Tumour is injectable i.t. by direct visualisation/palpation or by imaging-guidance (ultrasound). I.t. includes intracavitary injections, particularly intraperitoneal and intrapleural.
• Histological confirmation of primary disease or relapse.
• Patient has given signed informed consent.
• WHO performance score 0-1 and life expectancy more than 3 months.
• Previous anti-cancer treatment at least 1 month before Day 1.
• Tumour assessed to be suitable for biopsy.
• Hepatic, renal and bone marrow functions within normal limits for the target population as indicated by the following:
• Total bilirubin ≤ the upper limit of normal (ULN).
• ASAT, ALAT ≤3.0 × ULN.
• Serum creatinine ≤1.5 x ULN.
• International normalised ratio (INR) ≤1.5 x ULN.
• Haematologic parameters: Patients can be transfused to meet the haemoglobin and platelet count entry criteria.

You may not qualify if:

• Use of high dose systemic immune suppressive medication within 3 weeks of anticipated first treatment. Note: patients taking low-dose corticosteroids for the treatment of nausea and/or taking maintenance corticosteroids are permitted to enrol.
• Known infection with HIV or known underlying genetic immunodeficiency disease as these might affect the safety and efficacy of treatment.
• Treatment of the injected tumour(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks prior to the first treatment.
• Recent thromboembolic event (deep venous thrombosis, pulmonary embolism).
• Clinically significant active infection or clinically significant medical condition considered high risk for investigational new drug treatment (e.g. pulmonary, neurological, cardiovascular, metabolic, clinically significant and/or rapidly accumulating pericardial effusion).
• Severe or unstable cardiac disease.
• Known brain metastases, glioma. Central nervous system malignancy, including carcinomatosis meningitis.
• Pulse oximetry oxygen saturation \<90% at rest in room air.
• Vaccination with a live virus (i.e. measles, mumps, rubella, etc.) \<30 days prior to the first treatment.
• History of hepatic dysfunction, cirrhosis or hepatitis.
• Prior organ transplant.
• Pregnant or lactating patients.
• Evidence of coagulation disorder.
• Other conditions which, in the opinion of the investigator, might interfere with the study findings or represent a safety hazard for the patient.

Sponsors & Collaborators

• Targovax Oy: lead

Study Sites (1)

Docrates Hospital

Helsinki, 00180, Finland

Location

Related Publications (1)

• Ranki T, Pesonen S, Hemminki A, Partanen K, Kairemo K, Alanko T, Lundin J, Linder N, Turkki R, Ristimaki A, Jager E, Karbach J, Wahle C, Kankainen M, Backman C, von Euler M, Haavisto E, Hakonen T, Heiskanen R, Jaderberg M, Juhila J, Priha P, Suoranta L, Vassilev L, Vuolanto A, Joensuu T. Phase I study with ONCOS-102 for the treatment of solid tumors - an evaluation of clinical response and exploratory analyses of immune markers. J Immunother Cancer. 2016 Mar 15;4:17. doi: 10.1186/s40425-016-0121-5. eCollection 2016.

  PMID: 26981247 DERIVED

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Oncos Therapeutics

info@oncos.com

Study Officials

• Mikael von Euler, MD PhD

  Oncos Therapeutics Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: April 19, 2012
• First Posted: May 15, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 24, 2016
• Results First Posted: October 2, 2014

Record last verified: 2016-10

Locations

FI (1)