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Trial record 1 of 1 for:    CP-IVX001
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Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05427487
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : July 7, 2023
Information provided by (Responsible Party):
ImmVirx Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Gastroesophageal Cancer Ovarian Cancer Biological: IVX037 Phase 1

Detailed Description:

Participants will be enrolled by cohort, with a Safety Review Committee (SRC) reviewing any dose-limiting toxicities (DLT's) that develop within 21 days of the last dose of IVX037. If no DLT's are observed, the CRC may approve enrollment in the next study cohort.

Participants enrolled in the first two cohorts (one and two doses, respectively) who show stable disease or better at the Day 50 radiological assessment, may receive additional doses of IVX037, up to the maximum of 3 doses.

Following the dose escalation phase, up to 5 additional participants from each of the three tumour types, will be enrolled and receive IVX037 at the maximum tolerated dose. A total of fifteen (15) participants (5 from each of the 3 tumour types) at the maximum tolerated dose will provide paired tumour biopsies, one taken on Day 1 prior to IVX037 intratumoral injection and a second one taken two weeks later on Day 15. If the MTD occurs in Cohort 3, a third biopsy is requested on Day 29 (if possible) prior to IVX037 intratumoral injection. These biopsies will be used to assess for any changes in the tumour microenvironment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 open-label, non-randomized, multi-center clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Actual Study Start Date : February 17, 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IVX037
IVX037 administered intratumorally, 1, 2 or 3 doses q2wks, Day 1, 15 and 29 of Cycle 1.
Biological: IVX037
Bioselected oncolytic RNA virus

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities [ Time Frame: 21 days after following cessation of study intervention ]
    Assess the feasibility, safety, and tolerability of intratumoral IVX037 when administered to patients with advanced colorectal, ovarian or gastric cancers.

Secondary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 21 days after following cessation of study intervention ]
    To assess the maximum tolerated dose (MTD) of IVX037, administered as either 1, 2 or 3 injections per lesion, by CT or ultrasound guided intratumoral injection to patients with advanced colorectal, ovarian or gastric cancers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05427487

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Contact: Jennifer Rosenthal +61 (02) 4042 0232
Contact: Naomi Croll +61 (02) 4042 0232

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Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Mariz Selga         
Principal Investigator: Jia Liu, MD         
Westmead Public Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Jack Giannini         
Principal Investigator: Mark Wong, MD         
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Adelaide, South Australia, Australia, 5011
Contact: Elizabeth Egan         
Principal Investigator: Timothy Price, MD         
Australia, Victoria
The Austin Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Allison Collins         
Principal Investigator: Niall Tebbutt, MD         
Sponsors and Collaborators
ImmVirx Pty Ltd
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Study Chair: Darren Shafren ImmVirx Pty Ltd
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Responsible Party: ImmVirx Pty Ltd Identifier: NCT05427487    
Other Study ID Numbers: CP-IVX001
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmVirx Pty Ltd:
mCRC, CRC, cancer, virus