Trial Outcomes & Findings for ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers (NCT NCT01598129)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2016-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	CGTG-102 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 Study STARTED	12
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	CGTG-102 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 Study Disease progression	6
Overall Study Deterioration of WHO status to WHO 4	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGTG-102 n=12 Participants 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.
Age, Continuous	63 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment Finland	12 participants n=99 Participants
Number of cancer indications	9 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	CGTG-102 n=12 Participants 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.
Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.	12 participants

PRIMARY outcome

Timeframe: 6 months

No Dose Limiting Toxicities were observed at any dose level.

Outcome measures

Outcome measures
Measure	CGTG-102 n=12 Participants 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.
Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities	0 Dose limiting toxicities

SECONDARY outcome

Timeframe: 12 months

Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	CGTG-102 n=10 Participants 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.
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.	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 hours

Outcome measures

Outcome measures
Measure	CGTG-102 n=12 Participants 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.
An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.	12 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	CGTG-102 n=12 Participants 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.
Number of Participants With Infiltration of CD8+ T Cells Into Tumors.	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	CGTG-102 n=12 Participants 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.
Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.	2 participants

Adverse Events

CGTG-102

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CGTG-102 n=12 participants at risk 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.
Gastrointestinal disorders Duodenal obstruction and small intestinal hemorrhage	8.3% 1/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
Gastrointestinal disorders Colonic obstruction	8.3% 1/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
Musculoskeletal and connective tissue disorders Muscle rupture	8.3% 1/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
Hepatobiliary disorders Hypoalbuminemia and peripheral oedema	8.3% 1/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.

Other adverse events

Other adverse events
Measure	CGTG-102 n=12 participants at risk 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.
Surgical and medical procedures Pyrexia	100.0% 12/12 • Patients were followed up for Adverse Events throughout the study. There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.

Additional Information

Director, Clinical Operations

Oncos Therapeutics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60