Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
- Conditions
- Colorectal CancerGastric CancerOvarian Cancer
- Registration Number
- NCT05427487
- Lead Sponsor
- ImmVirx Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A participant will be eligible for inclusion in the study if the participant:<br><br> 1. Has either a histologically confirmed advanced colorectal, gastric/gastroesophageal<br> adenocarcinoma, or ovarian cancer that has progressed or is not suitable for<br> standard of care systemic therapies. Participants with colorectal cancer must have<br> either a primary tumor or a biopsy of a metastatic tumor which has been shown to<br> lack microsatellite instability (by PCR) or to have normal expression of mismatch<br> repair enzymes (by immunohistochemistry). That is, a mismatch repair proficient mCRC<br> tumor.<br><br> 2. Progressed on or after at least one prior line of systemic therapy and must not have<br> had more than 3 prior lines. Phase 1b only: participants with gastroesophageal<br> cancer must have failed prior treatment with an immune checkpoint inhibitor.<br><br> 3. Has at least one injectable tumor that meets RECIST1.1 criteria to be designated as<br> a target lesion, and is:<br><br> 1. a liver lesion 1.0 to 6.5 cm (longest diameter) meeting RECIST criteria on<br> baseline CT scan or MRI and suitable for injection under CT or ultrasound<br> guidance, and participant has an estimated total tumor burden of disease < 1/3<br> of liver volume based on CT or MRI imaging, or<br><br> 2. A measurable lymph node, i.e., with a short axis diameter (SAD) of 1.5 cm to<br> 6.5 cm, or<br><br> 3. Other solid tumor with a longitudinal diameter 1.0 cm to 6.5 cm.<br><br> 4. No other lesions (including non-injected lesions) greater than 6.5 cm (longest<br> diameter).<br><br> Note (i): Only 2 target lesions may be designated in any one organ but if an organ<br> such as the liver has more than 2 lesions which can be injected, the others, up to 3<br> additional, may be designated as NTLs and injected. Alternatively, target and<br> non-target lesions elsewhere up to a total of 5 may be selected for injection.<br><br> Note (ii): Tumor lesions located in areas previously subjected to radiation or other<br> locoregional therapies are not considered measurable unless there is a demonstrated<br> progression in that lesion, as determined by the Investigator.<br><br> 4. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)<br> performance scale.<br><br> 5. Has demonstrated adequate organ function defined in the protocol, from samples<br> collected within 72 hours prior to the start of treatment.<br><br> 6. Is a male or female from 18 to 85 years or age at the time of signing the informed<br> consent.<br><br> 7. Must be willing to abstain from activities or use proper birth control methods for<br> the duration of the study:<br><br> 1. Female participants of child-bearing potential must be willing to use an<br> adequate method of contraception. Contraception, starting with the first dose<br> of study therapy through 120 days after the last dose of study therapy. Note:<br> Abstinence is acceptable if this is the usual lifestyle and preferred<br> contraception for the participant.<br><br> 2. Male participants of child-bearing potential must agree to use an adequate<br> method of contraception. Contraception, starting with the first dose of study<br> therapy through 120 days after the last dose of study therapy. Note: Abstinence<br> is acceptable if this is the usual lifestyle and preferred contraception for<br> the participant.<br><br> 8. The participant (or their legally acceptable representative if applicable) has<br> provided written, informed consent prior to the initiation of any study procedures.<br><br> 9. Female participants of child-bearing potential must have a negative urine pregnancy<br> test within 72 hours prior to receiving the first dose of study medication. If a<br> urine test is positive or cannot be confirmed as negative, a serum pregnancy test is<br> required.<br><br> 10. Participants must have fully recovered to NCI-CTCAE Grade 1 or better from AEs due<br> to all previous anticancer therapies prior to entering this study. Note:<br> Participants with Grade = 2 AEs that are deemed not clinically significant by the<br> Investigator may qualify for the study with approval by the Sponsor.<br><br> 11. The participant has a life expectancy of greater than 6 months.<br><br>Participants are excluded from the study if any of the following criteria apply:<br><br>Medical Conditions<br><br> 1. The potential participant is deemed to be a candidate for hepatic surgery or<br> locoregional therapy for liver lesions with curative intent or requires other<br> systemic anti-cancer therapy.<br><br> 2. The participant has clinically significant ascites (Grade =2).<br><br> 3. Participants with any other concurrent uncontrolled illness, including mental<br> illness or substance abuse, which may interfere with the ability of the participant<br> to cooperate and participate in the trial; other examples of such conditions would<br> include unstable or uncontrolled hypertension, unstable angina, myocardial<br> infarction or cerebrovascular accident within 6 months of study entry.<br><br> 4. The participant requires continuous systemic treatment with either corticosteroids<br> (>10 mg daily prednisone or equivalent) or other immunosuppressive medications<br> within 4 weeks prior to the first dose of study treatment. Single doses of<br> corticosteroids for prophylaxis of allergic reactions during imaging studies with<br> contrast are allowed within 4 weeks of study treatment.<br><br> 5. The participant has not fully recovered from any effects of major surgery without<br> significant detectable infection. Surgeries that require general anesthesia must<br> have been completed at least 2 weeks before first dose of IVX037.<br><br> 6. Participants with bleeding diathesis due to underlying medical conditions or the use<br> of anticoagulation medications that is unable to be reversed by medical treatment.<br><br> 7. Participants with tumors that lie close to an airway, major blood vessel or spinal<br> cord, which, in the opinion of the Investigator, could cause occlusion, compression,<br> or erosion of the vital structures.<br><br> 8. Participants with multi-focal miliary disease without critical target lesions.<br> Prior/Concomitant Therapy<br><br> 9. Participants who have been previously treated with an immune checkpoint inhibitor<br> (e.g., an anti-CTLA-4, anti-PD-1 or anti-PD-L1) must have completed their last dose<br> at least 28 days prior to Day 1 and have demonstrated progressive disease during or<br> following the immune checkpoint inhibitor therapy. The participant must also have no<br> medical history of immune mediated adverse events including infusion<br> (hypersensitivity) reactions = Grade 3 (CTCAE), with the exceptions of adequately<br> treated hypothyroidism and type 1 diabetes mellitus (hyperglycemia) resulting from<br> past treatment with an immune checkpoint inhibitor and non-exfoliative dermatologic<br> reactions such as vitiligo. A history of Grade 2 immune-mediated infusion reactions<br> to an immune checkpoint inhibitor while receiving adequate prophylactic treatment<br> for hypersensitivity reactions is also exclusionary.<br><br> 10. Participants who require prohibited treatments (i.e., non-protocol-specified<br> anticancer pharmacotherapy, surgery, or radiotherapy for treatment of malignancy).<br> Prohibited medications must be ceased at least 21 days or 5 half-lives (whichever is<br> longer) prior to Day 1.<br><br> Pri
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1a - feasibility, safety, and tolerability of intratumoral IVX037 when administered to patients with advanced colorectal, ovarian or gastric cancers;Phase 1b - safety and efficacy of intratumoral IVX037 in combination with an intravenous immune checkpoint inhibitor
- Secondary Outcome Measures
Name Time Method