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Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05427487•ImmVirx Pty Ltd

View on ClinicalTrials.gov

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.

Detailed Description

In Phase 1a, participants are treated with IVX037 alone by intratumoral administration as monotherapy. Participants will be enrolled by cohort, with a Safety Review Committee (SRC) reviewing any dose-limiting toxicities (DLTs) that develop within 21 days after the first, second, or third dose of IVX037 for Cohorts 1, 2 and 3, respectively. Cohorts in the dose escalation will consist of 3-6 participants. Participants in Cohort 3 are permitted to receive up to seven doses of IVX037 in the absence of DLTs and at the discretion of the Investigator. The SRC will review Cohort 3 safety data once three participants have completed three doses of IVX037 and 21-days of safety data is available and will make a recommendation as to whether the dose expansion phase may commence. In the dose expansion phase, up to 5 additional participants from each of the three tumor types will be enrolled and receive IVX037 at the MTD. A total of fifteen (15) participants (5 from each of the 3 tumor types) at the maximum tolerated dose will provide paired tumor biopsies, one taken on Day 1 prior to IVX037 intratumoral injection and a second one taken two weeks later on Day 15. In Part 1b, a total of 45 participants (15 from each of the three tumor types) will be enrolled and receive the number of intratumoral doses of IVX037 that were deemed safe during Part 1a, in combination with an intravenous (IV) immune checkpoint inhibitor, sintilimab. Sintilimab administration will commence on Study Day 8 and be administered every three weeks (Q3wks) at 200 mg/dose through to Study Day 344.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. Has at least one injectable tumor that meets RECIST1.1 criteria to be designated as a target lesion, and is:
•1. 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
•2. A measurable lymph node, i.e., with a short axis diameter (SAD) of 1.5 cm to 6.5 cm, or
•3. Other solid tumor with a longitudinal diameter 1.0 cm to 6.5 cm.
•4. 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.
•4. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
+9 more criteria

Exclusion Criteria

•Medical Conditions
•1. 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.
•2. The participant has clinically significant ascites (Grade ≥2).
•3. 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.
•4. 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.
•5. 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.
•6. Participants with bleeding diathesis due to underlying medical conditions or the use of anticoagulation medications that is unable to be reversed by medical treatment.
•7. 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.
•8. Participants with multi-focal miliary disease without critical target lesions. Prior/Concomitant Therapy
•9. 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 progressive disease during or following the immune checkpoint inhibitor therapy. The participant must also have no medical history of immune mediated adverse events including infusion (hypersensitivity) reactions ≥ Grade 3 (CTCAE), with the exceptions of adequately treated hypothyroidism and type 1 diabetes mellitus (hyperglycemia) resulting from past treatment with an immune checkpoint inhibitor and non-exfoliative dermatologic reactions such as vitiligo. A history of Grade 2 immune-mediated infusion reactions to an immune checkpoint inhibitor while receiving adequate prophylactic treatment for hypersensitivity reactions is also exclusionary.
+17 more criteria

Locations (3)

Sydney site

Sydney, New South Wales, Australia

South Australia site

Adelaide, South Australia, Australia

Melbourne Site

Melbourne, Victoria, Australia

Key Dates

Start Date

February 17, 2023

Primary Completion Date

September 30, 2026

Completion Date

November 30, 2026

Last Updated

February 25, 2025

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerGastric CancerOvarian Cancer

Interventions

IVX037

BIOLOGICAL

Sintilimab

BIOLOGICAL

Contacts

Oksana Zdanska

CONTACT

+61 (02) 4042 0165 oksana.zdanska@immvirx.com

Jennifer Rosenthal

CONTACT

+61 (02) 4042 0165 jen.rosenthal@immvirx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

Inclusion Criteria

Exclusion Criteria

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