Malignant Solid TumourPhase 1NCT01598129
ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers
A Phase 1 study testing ONCOS-102 in people with Malignant Solid Tumour, run by Targovax Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- ONCOS-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2012to Oct 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
- Haemoglobin ≥10 g/dL
- Leucocytes ≥2.3 x 109/L
- Platelet count ≥7.5 x 109/L
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Open Label Study of GM-CSF Coding Oncolytic Adenovirus CGTG-102, With Low Dose Cyclophosphamide in Patients With Refractory Injectable Solid Tumours
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.
Read the detailed description
CGTG-102 is an adenovirus that has been armed with granulocyte-macrophage colony stimulating factor (GMCSF), a potent stimulator of immunological cells.
With regard to oncolytic viruses, replication in normal cells does not take place, and therefore viruses such as CGTG-102 are not known to cause any disease. Further, to date there has been no incidence of passing the virus on to other humans from patients. Since the virus requires tumor cells to multiply, such events are unlikely.
To this day more than 100 patients have been treated with CGTG-102. This clinical trial will take place over approximately 6 months. The study includes 12 visits to the hospital, 1 screening visit, 9 injection visits including overnight stay at the hospital(performed on trial days 1, 4, 8, 15, 29, 57, 85, 113 and 141), 1 end of treatment visit (day 169) and 1 end of study visit (day 190). Oral treatment with cyclophosphamide (1 pill per day) will start on the day after the first injection and last until visit day 169.
- Conditions
- Malignant Solid Tumour
- Being tested
- ONCOS-102
- Keywords
- Phase I, Dose escalation, oncolytic virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOS-102Genetic
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.
| Study group | Role | What they receive |
|---|---|---|
| CGTG-102 | Experimental | CGTG-102 dose escalation Receives: Genetic: ONCOS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.
Measured: 6 months
Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities
No Dose Limiting Toxicities were observed at any dose level.
Measured: 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.
Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targovax Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikael von Euler, MD PhD, Study director, Oncos Therapeutics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598129
- Sponsor's protocol ID
- Oncos-C1
- Status last verified
- Oct 2016
- First submitted
- 19 Apr 2012
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26981247
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Open Label Study of GM-CSF Coding Oncolytic Adenovirus CGTG-102, With Low Dose Cyclophosphamide in Patients With Refractory Injectable Solid Tumours
- ClinicalTrials.gov ID
- NCT01598129
- Acronym / sponsor ID
- Oncos-C1
- Conditions
- Malignant Solid Tumour
- Keywords
- Phase I, Dose escalation, oncolytic virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Targovax OyIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CGTG-102 is an adenovirus that has been armed with granulocyte-macrophage colony stimulating factor (GMCSF), a potent stimulator of immunological cells.
With regard to oncolytic viruses, replication in normal cells does not take place, and therefore viruses such as CGTG-102 are not known to cause any disease. Further, to date there has been no incidence of passing the virus on to other humans from patients. Since the virus requires tumor cells to multiply, such events are unlikely.
To this day more than 100 patients have been treated with CGTG-102. This clinical trial will take place over approximately 6 months. The study includes 12 visits to the hospital, 1 screening visit, 9 injection visits including overnight stay at the hospital(performed on trial days 1, 4, 8, 15, 29, 57, 85, 113 and 141), 1 end of treatment visit (day 169) and 1 end of study visit (day 190). Oral treatment with cyclophosphamide (1 pill per day) will start on the day after the first injection and last until visit day 169.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGTG-102 | Experimental | Genetic: ONCOS-102CGTG-102 dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONCOS-102GMCSF 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. | Genetic | CGTG-102 |
Primary outcome
Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.
Time frame: 6 months
Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities
Time frame: 6 months
No Dose Limiting Toxicities were observed at any dose level.
1 secondary outcome
To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26981247Ranki 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.
Related trials for Malignant Solid Tumour
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael von Euler, MD PhD study director
Oncos Therapeutics Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONCOS-102 in people with Malignant Solid Tumour, run by Targovax Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.