Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
A Phase 1 Open-label, Non-randomized, Multi-cohort Clinical Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
1 other identifier
interventional
70
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Feb 2023
Longer than P75 for phase_1 colorectal-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Start
First participant enrolled
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
March 25, 2026
March 1, 2026
5.4 years
June 16, 2022
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1a - feasibility, safety, and tolerability of intratumoral IVX037 when administered to patients with advanced colorectal, ovarian or gastric cancers
Incidence of dose-limiting toxicities (DLTs), viral excretion, adverse events (AEs), serious adverse events (SAEs) and changes from baseline in clinical chemistry and hematology laboratory values. Safety overall will be measured by CTCAE v5.
21 days after following cessation of study intervention
Phase 1b - safety and efficacy of intratumoral IVX037 in combination with an intravenous immune checkpoint inhibitor
Viral excretion, incidence and severity of AEs, SAEs, and changes from baseline in clinical chemistry and hematology laboratory values. Efficacy will be assessed through iRECIST.
21 days after following cessation of study intervention
Study Arms (2)
Part 1a
EXPERIMENTALIVX037 administered intratumorally, 1, 2 or 3 doses q2wks, Day 1, 15 and 29.
Part 1b
EXPERIMENTALIVX037 administered intratumorally 3 doses q2wks, for up to 7 doses. Sintilimab administration will commence on Study Day 8 and be administered every three weeks (Q3wks) at 200 mg/dose through to Study Day 344.
Interventions
Eligibility Criteria
You may qualify if:
- Has either a 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 tumor or a biopsy of a metastatic tumor 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 tumor.
- Progressed on or after at least one prior line of systemic therapy and must not have had more than 3 prior lines. Phase 1b only: participants with gastroesophageal cancer must have failed prior treatment with an immune checkpoint inhibitor.
- Has at least one injectable tumor that meets RECIST1.1 criteria to be designated as a target lesion, and is:
- a liver lesion 1.0 to 6.5 cm (longest diameter) meeting RECIST criteria on baseline CT scan or MRI and suitable for injection under CT or ultrasound guidance, and participant has an estimated total tumor burden of disease \< 1/3 of liver volume based on CT or MRI imaging, or
- A measurable lymph node, i.e., with a short axis diameter (SAD) of 1.5 cm to 6.5 cm, or
- Other solid tumor with a longitudinal diameter 1.0 cm to 6.5 cm.
- No other lesions (including non-injected lesions) greater than 6.5 cm (longest diameter).
- Note (i): Only 2 target lesions may be designated in any one organ but if an organ such as the liver has more than 2 lesions which can be injected, the others, up to 3 additional, may be designated as NTLs and injected. Alternatively, target and non-target lesions elsewhere up to a total of 5 may be selected for injection.
- Note (ii): Tumor lesions located in areas previously subjected to radiation or other locoregional therapies are not considered measurable unless there is a demonstrated progression in that lesion, as determined by the Investigator.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- Has demonstrated adequate organ function defined in the protocol, from samples collected within 72 hours prior to the start of treatment.
- Is a male or female from 18 to 85 years or age at the time of signing the informed consent.
- Must be willing to abstain from activities or use proper birth control methods for the duration of the study:
- Female participants of child-bearing potential must be willing to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- Male participants of child-bearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- +4 more criteria
You may not qualify if:
- Medical Conditions
- The potential participant is deemed to be a candidate for hepatic surgery or locoregional therapy for liver lesions with curative intent or requires other systemic anti-cancer therapy.
- The participant has clinically significant ascites (Grade ≥2).
- Participants with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the participant to cooperate and participate in the trial; other examples of such conditions would include unstable or uncontrolled hypertension, unstable angina, myocardial infarction or cerebrovascular accident within 6 months of study entry.
- The participant 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. Single doses of corticosteroids for prophylaxis of allergic reactions during imaging studies with contrast are allowed within 4 weeks of study treatment.
- The participant has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that require general anesthesia must have been completed at least 2 weeks before first dose of IVX037.
- Participants with bleeding diathesis due to underlying medical conditions or the use of anticoagulation medications that is unable to be reversed by medical treatment.
- Participants with 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.
- Participants with multi-focal miliary disease without critical target lesions. Prior/Concomitant Therapy
- Participants who require prohibited treatments (i.e., non-protocol-specified anticancer pharmacotherapy, surgery, or radiotherapy for treatment of malignancy). Prohibited medications must be ceased at least 21 days or 5 half-lives (whichever is longer) prior to Day 1.
- Prior/Concurrent Clinical Study Experience
- Is currently participating and receiving other study therapy including an investigational agent or device within 4 weeks of Day 1.
- Participants who have received a live vaccine within 4 weeks of the first day of planned IVX037 treatment or any other vaccine including killed virus and mRNA vaccines within 2 weeks of the first day of planned IVX037 treatment.
- Diagnostic Assessments
- Participant with active (i.e., symptomatic or growing) central nervous system (CNS) metastases. Participants with CNS metastases are eligible for the trial if the metastases have been treated by surgery and/or radiotherapy, the participant is off corticosteroids for at least 2 weeks prior to first dose of IVX037 and have stable disease on imaging for 3 months prior to Day 1.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ImmVirx Pty Ltdlead
- Innovent Biologics (Suzhou) Co. Ltd.collaborator
Study Sites (3)
Sydney site
Sydney, New South Wales, 2000, Australia
South Australia site
Adelaide, South Australia, 5000, Australia
Melbourne Site
Melbourne, Victoria, 3000, Australia
Related Publications (2)
Liu J., Tebbutt, N., Price, T., Hus, E., Al-Asady, R., Shafren, D., Zdanska, O., Croll, N., Wong, M. Phase 1a/b open-label, non-randomized, multi-centre clinical trial of intratumoral IVX037 alone and in combination with anti-PD1 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer: trial in progress. Medical Oncology Group of Australia (MOGA) Sydney, Australia Conference Poster 2024
RESULTLiu, J., Price, T., Tebbutt, N., Hsu, E., Al-Asady, R., Shafren, D., Croll, N., Wong, M. Phase 1a open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer. SITC 2023 Poster Presentation. Abstract Number 649
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Darren Shafren
ImmVirx Pty Ltd
- STUDY DIRECTOR
Oksana Zdanska
ImmVirx Pty Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
June 22, 2022
Study Start
February 17, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
March 25, 2026
Record last verified: 2026-03