Actively Recruiting
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Led by ImmVirx Pty Ltd · Updated on 2026-03-25
70
Participants Needed
3
Research Sites
301 weeks
Total Duration
On this page
Sponsors
I
ImmVirx Pty Ltd
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS) colorectal cancer, or gastric or ovarian cancer. The study is run in 2 parts. Phase 1a is dose escalation IVX037 monotherapy and Phase 1b is IVX037 with checkpoint inhibitor, sintilimab.
CONDITIONS
Official Title
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinoma, or ovarian cancer that has progressed or is unsuitable for standard systemic therapies
- Colorectal cancer must be mismatch repair proficient
- Progressed on or after at least one prior systemic therapy and not more than three prior lines
- For Phase 1b, gastroesophageal cancer patients must have failed prior immune checkpoint inhibitor treatment
- At least one injectable tumor lesion meeting size and location criteria suitable for intratumoral injection
- ECOG performance status of 0 or 1
- Adequate organ function based on recent tests
- Male or female aged 18 to 85 years at informed consent
- Willingness to use proper birth control during and 120 days after study treatment
- Written informed consent provided
- Female participants of childbearing potential must have a negative pregnancy test before first dose
- Fully recovered to Grade 1 or better from adverse events of previous cancer therapies
- Life expectancy greater than 6 months
You will not qualify if you...
- Candidate for hepatic surgery or locoregional therapy with curative intent or requiring other systemic anti-cancer therapy
- Clinically significant ascites (Grade 2 or higher)
- Uncontrolled illness including mental illness or substance abuse affecting participation
- Continuous systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 4 weeks prior to first dose
- Not fully recovered from major surgery or with infection; surgery requiring general anesthesia must be at least 2 weeks before first dose
- Bleeding disorders not reversible by treatment
- Tumors near vital structures that risk occlusion or erosion
- Multifocal miliary disease without critical target lesions
- Prior immune checkpoint inhibitor treatment unless progressive disease and no severe immune adverse events
- Use of prohibited treatments within 21 days before first dose
- Participation in another clinical study with treatment within 4 weeks before first dose
- Recent live vaccine within 4 weeks or other vaccines within 2 weeks before first dose
- Active or growing CNS metastases unless stable after treatment and off steroids for 2 weeks
- Known HIV, active Hepatitis B or C infection
- Severe or uncontrolled infection
- History of other malignancies within 3 years except certain low-risk cancers
- History of drug-induced lung disease requiring steroids except radiation-induced
- History of organ transplantation
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of primary immunodeficiency
- Evidence or recent hospitalization for small bowel obstruction
- Conditions or abnormalities that may interfere with trial participation or safety
- Pregnant or breastfeeding or planning conception during study and 120 days after last dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Sydney site
Sydney, New South Wales, Australia, 2000
Actively Recruiting
2
South Australia site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
3
Melbourne Site
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
O
Oksana Zdanska
CONTACT
J
Jennifer Rosenthal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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