OncoMatch/Clinical Trials/NCT05427487
Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Is NCT05427487 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including IVX037 and Sintilimab for colorectal cancer.
Treatment: IVX037 · Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05427487 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and immune checkpoint inhibitor.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages