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OncoMatch/Clinical Trials/NCT05427487

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

Is NCT05427487 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IVX037 and Sintilimab for colorectal cancer.

Phase 1RecruitingImmVirx Pty LtdNCT05427487Data as of May 2026

Treatment: IVX037 · SintilimabThis 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Gastric Cancer

Ovarian Cancer

Biomarker criteria

Required: MMR proficient (normal expression of mismatch repair enzymes by IHC or lack of microsatellite instability by PCR)

colorectal cancer must have...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.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: systemic therapy

Progressed on or after at least one prior line of systemic therapy and must not have had more than 3 prior lines.

Must have received: immune checkpoint inhibitor — gastroesophageal cancer, Phase 1b only

Phase 1b only: participants with gastroesophageal cancer must have failed prior treatment with an immune checkpoint inhibitor.

Lab requirements

Blood counts

adequate organ function defined in the protocol

Kidney function

adequate organ function defined in the protocol

Liver function

adequate organ function defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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