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RecruitingLast updated: 2 February 2024

CP-IVX001: This study is looking into the safety and effectiveness of a new drug (IVX037) in people with advanced bowel, stomach, oesophagus or ovarian cancerA Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

Clinical summary

Summary

This is a dose escalation and dose expansion study recruiting people with advanced colorectal, gastric/gastro-oesophageal, or ovarian cancer that has progressed (or is not suitable for) standard of care systemic therapy. 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 or to have normal expression of mismatch repair enzymes. The first part of this study is a dose escalation part. Participants will be enrolled one of two cohorts. Each cohort will be testing a different dose level of the study drug (IVX037). IVX037 will be given as an injection into the tumour (intratumoural injection). The second part of this study is a dose expansion phase. In this part, a total of 15 participants will be enrolled to receive IVX037 at the maximum tolerated dose level identified in the dose escalation part.

Conditions

This trial is treating patients with advanced colorectal, gastric/gastro-oesophageal, or ovarian cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 85

Phase

I

Trial Acronym

CP-IVX001

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

ImmVirx Pty Ltd

Scientific Title

A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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