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New treatment option for Colorectal Cancer
Official title Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
ClinicalTrials.gov ID: NCT05427487
What this study is testing
What is IVX037?
IVX037 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Has either a histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinoma, or ovarian cancer that has progressed or is not...
- 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...
- 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...
- A measurable lymph node, i.e., with a short axis diameter (SAD) of 1.5 cm to 6.5 cm, or
You likely can't join 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...
- 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...
- The participant requires continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other...
- The participant has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that require general...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- The participant (or their legally acceptable representative if applicable) has provided written, informed consent prior to the initiation of any study procedures.
- 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. If a urine test is positive or cannot be confirmed as...
- Participants must have fully recovered to NCI-CTCAE Grade 1 or better from AEs due to all previous anticancer therapies prior to entering this study. Note: Participants with Grade ≤ 2 AEs that are deemed not clinically...
- The participant has a life expectancy of greater than 6 months.
What rules you out
- 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...
- 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...
- 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...
- 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 have been previously treated with an immune checkpoint inhibitor (e.g., an anti-CTLA-4, anti-PD-1 or anti-PD-L1) must have completed their last dose at least 28 days prior to Day 1 and have demonstrated...
- 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...
- 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...
- 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...
- Participant has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Note: no testing for...
- Participant has a severe infection or other uncontrolled active infectious disease requiring treatment that would interfere with the evaluation of safety and how well it works or is not in the best interest of the...
- Has a history of other malignancies within the previous 3 years, except for locally curable cancers which have been apparently cured such as basal cell or squamous cell skin cancer, superficial bladder cancer or...
- Has a history of drug-induced interstitial lung disease or non-infectious pneumonitis requiring steroids, except for those induced by radiation therapies.
- Has a history of a prior organ transplantation, including allogenic stem-cell transplantation.
- Has an active or known documented autoimmune disease within the past 2 years that has required systemic treatment.
- Has a history of primary immunodeficiency.
- Has an evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, or recent hospitalization for small bowel obstruction within 3 months prior to starting trial treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or...
- Is 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.