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

• Biological: IVX037
• Biological: Sintilimab

Inclusion Criteria

1. Has either a histologically confirmed advanced colorectal, gastric/gastroesophageal adenocarcinomacancer arising from mucus-producing glands in organs, 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 biopsyremoval of a section of tissue to analyse for cancer cells 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 ultrasounda type of medical imaging that uses soundwaves to create detailed images of the body   guidance, and participant has an estimated total tumor burden of disease < 1/3 of liver volume based on CT or MRI imagingtests that create detailed images of areas inside the body, or
   2. A measurable lymph nodea small lump or mass of tissue in your body, 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance scale.
5. Has demonstrated adequate organ function defined in the protocol, from samples collected within 72 hours prior to the start of treatment.
6. Is a male or female from 18 to 85 years or age at the time of signing the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
7. Must be willing to abstain from activities or use proper birth control methods for the duration of the study:
   1. 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.
   2. 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.
8. The participant (or their legally acceptable representative if applicable) has provided written, informed consent prior to the initiation of any study procedures.
9. 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 negative, a serum pregnancy test is required.
10. Participants must have fully recovered to NCI-CTCAE Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 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 significant by the Investigator may qualify for the study with approval by the Sponsor.
11. The participant has a life expectancy of greater than 6 months.