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

• ClinicalTrials.gov Identifier: NCT01598129
• Recruitment Status: Completed
• First Posted: May 15, 2012
• Results First Posted: October 2, 2014
• Last Update Posted: October 24, 2016
• Sponsor: Targovax Oy
• Information provided by (Responsible Party): Targovax ASA ( Targovax Oy )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Malignant Solid Tumour
• Intervention: Genetic: ONCOS-102
• Enrollment: 12

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CGTG-102
Arm/Group Description	CGTG-102 dose escalation CGTG-102: 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.
Period Title: Overall Study
Started	12
Completed	3
Not Completed	9
Reason Not Completed
Disease progression	6
Deterioration of WHO status to WHO 4	2
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		CGTG-102
Arm/Group Description		CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Baseline Participants		12
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	12 participants
		63; (38 to 68)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants
	Female	7 58.3%
	Male	5 41.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Finland	Number Analyzed	12 participants
		12
Number of cancer indications; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	12 participants
		9

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Participants Analyzed	12
Measure Type: Number; Unit of Measure: participants
	12

2. Primary Outcome

Title	Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities
Description	No Dose Limiting Toxicities were observed at any dose level.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation ONCOS-102: 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.
Overall Number of Participants Analyzed	12
Measure Type: Number; Unit of Measure: Dose limiting toxicities
	0

3. Secondary Outcome

Title	To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.
Description	Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.
Time Frame	12 months

Outcome Measure Data Not Reported

4. Other Pre-specified Outcome

Title	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.
Description	[Not Specified]
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: participants
	4

5. Other Pre-specified Outcome

Title	Quality of Life Using EORTC QLQ-C30.
Description	To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.
Time Frame	12 months

Outcome Measure Data Not Reported

6. Other Pre-specified Outcome

Title	An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.
Description	[Not Specified]
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Participants Analyzed	12
Measure Type: Number; Unit of Measure: participants
	12

7. Other Pre-specified Outcome

Title	Number of Participants With Infiltration of CD8+ T Cells Into Tumors.
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Participants Analyzed	12
Measure Type: Number; Unit of Measure: participants
	11

8. Other Pre-specified Outcome

Title	Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CGTG-102
Arm/Group Description:	CGTG-102 dose escalation CGTG-102: 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.
Overall Number of Participants Analyzed	12
Measure Type: Number; Unit of Measure: participants
	2

Adverse Events

Time Frame	Patients were followed up for Adverse Events throughout the study.
Adverse Event Reporting Description	There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
Arm/Group Title	CGTG-102
Arm/Group Description	CGTG-102 dose escalation CGTG-102: 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.
All-Cause Mortality
	CGTG-102
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	CGTG-102
	Affected / at Risk (%)
Total	5/12 (41.67%)
Gastrointestinal disorders
Duodenal obstruction and small intestinal hemorrhage	1/12 (8.33%)
Colonic obstruction	1/12 (8.33%)
Abdominal pain	1/12 (8.33%)
Hepatobiliary disorders
Hypoalbuminemia and peripheral oedema	1/12 (8.33%)
Musculoskeletal and connective tissue disorders
Muscle rupture	1/12 (8.33%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	CGTG-102
	Affected / at Risk (%)
Total	12/12 (100.00%)
Surgical and medical procedures
Pyrexia	12/12 (100.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Director, Clinical Operations
• Organization: Oncos Therapeutics
• EMail: info@oncos.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ranki T, Pesonen S, Hemminki A, Partanen K, Kairemo K, Alanko T, Lundin J, Linder N, Turkki R, Ristimäki A, Jäger 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.

• Responsible Party: Targovax ASA ( Targovax Oy )
• ClinicalTrials.gov Identifier: NCT01598129
• Other Study ID Numbers: Oncos-C1
• First Submitted: April 19, 2012
• First Posted: May 15, 2012
• Results First Submitted: June 11, 2014
• Results First Posted: October 2, 2014
• Last Update Posted: October 24, 2016