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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05427487




Registration number
NCT05427487
Ethics application status
Date submitted
16/06/2022
Date registered
22/06/2022
Date last updated
7/07/2023

Titles & IDs
Public title
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Scientific title
A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Secondary ID [1] 0 0
CP-IVX001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Gastroesophageal Cancer 0 0
Ovarian Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IVX037

Experimental: IVX037 - IVX037 administered intratumorally, 1, 2 or 3 doses q2wks, Day 1, 15 and 29 of Cycle 1.


Other interventions: IVX037
Bioselected oncolytic RNA virus
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities
Timepoint [1] 0 0
21 days after following cessation of study intervention
Secondary outcome [1] 0 0
Maximum tolerated dose
Timepoint [1] 0 0
21 days after following cessation of study intervention

Eligibility
Key inclusion criteria
1.1. Inclusion Criteria

1. Histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinoma,
or ovarian cancer that has progressed or is not suitable for standard of care systemic
therapies. Participants with colorectal cancer must have either a primary tumour or a
biopsy of a metastatic tumour which has been shown to lack microsatellite instability
(by PCR) or to have normal expression of mismatch repair enzymes (by
immunohistochemistry). That is, a mismatch repair proficient mCRC tumour.

2. At least one injectable tumour that meets RECIST1.1 criteria to be designated as a
target lesion, and is:

1. a liver lesion = 2 cm and = 8 cm on baseline CT scan or MRI and suitable for
injection under CT or ultrasound guidance, and has an estimated tumour volume <
1/3 of liver volume based on CT or MRI imaging, and no single metastatic lesion >
8 cm, or

2. At least two tumours consisting of a measurable lymph node, i.e., with a short
axis diameter (SAD) of = 15 mm and/or other solid tumour with a longitudinal
diameter = 10 mm.

3. Phase 1a at MTD dose: Fifteen (15) participants (5 of each tumour type) must provide a
biopsy (core needle, minimum 18 gauge) on Day 1 and Day 15.

4. ECOG 0 or 1.

5. Has adequate organ function defined in the protocol.

6. Male or female 18 to 85 years of age.

7. Must abstain from activities or use proper birth control methods for the duration of
the study as defined in the protocol.

8. Written, informed consent prior to the initiation of any study procedures.

9. Female participants of child-bearing potential must have a negative urine pregnancy
test within 72 hours prior to receiving the first dose of study medication.

10. Life expectancy > 6 months.

1.2.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Medical Conditions

1. Candidate for hepatic surgery or locoregional therapy for liver lesions with curative
intent or requires other systemic anti-cancer therapy.

2. Clinically significant ascites (Grade =2).

3. Other concurrent uncontrolled illness, including mental illness or substance abuse,
which may interfere with the ability of the subject to cooperate and participate in
the trial; other examples of such conditions would include unstable or uncontrolled
hypertension, unstable angina, myocardial infarction (MI) or cerebrovascular accident
(CVA) within 6 months of study entry.

4. Requires continuous systemic treatment with either corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive medications within 4 weeks prior
to the first dose of study treatment should be an EC.

5. Has not fully recovered from any effects of major surgery without significant
detectable infection.

6. Bleeding diathesis due to underlying medical conditions or the use of anticoagulation
medications that is unable to be reversed by medical treatment.

7. Tumors that lie close to an airway, major blood vessel or spinal cord, which, in the
opinion of the Investigator, could cause occlusion, compression, or erosion of the
vital structures.

Prior/Concomitant Therapy

8. Participants who have been previously treated with an immune checkpoint inhibitor must
have completed their last dose at least 21 days prior to Day 1, as long as there is
demonstrated progressive disease during, or following the immune checkpoint inhibitor
therapy.

9. Participants who require prohibited treatments (i.e., non-protocol-specified
anticancer pharmacotherapy, surgery, or radiotherapy for treatment of malignancy).

Prior/Concurrent Clinical Study Experience

10. Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.

11. Participants who have received a live or inactivated vaccine within 4 weeks of the
first day of planned IVX037 treatment.

Diagnostic Assessments

12. Participant with active (i.e., symptomatic or growing) CNS metastases. .

13. Participant has a known history of HIV

14. Active infection requiring systemic therapy.

15. Known additional malignancy that is progressing or requires active treatment.

16. A history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.

Other Exclusions

17. Pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the trial, starting with the Screening visit through 120 days
after the last dose of trial treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [2] 0 0
Westmead Public Hospital - Westmead
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
The Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmVirx Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral
IVX037 in people with micro satellite-stable (MSS) colorectal or gastroesophageal cancer
metastatic to liver, or advanced ovarian cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05427487
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darren Shafren
Address 0 0
ImmVirx Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Rosenthal
Address 0 0
Country 0 0
Phone 0 0
+61 (02) 4042 0232
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05427487