Phase 2 study
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| St John of God Subiaco Hospital | Subiaco | WA | Recruiting |
| Cancer Research SA Pty Ltd | Adelaide | SA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 13 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Key Inclusion Criteria:
• All study cohorts
* Participant has histologically or cytologically confirmed GI cancer.
* Participant has documented metastatic or unresectable disease, not amenable to treatment with curative intent.
* Participant has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at baseline.
* Participant must have radiological disease progression while on or after receiving the most recent regimen.
* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participant has life expectancy ≥3 months.
* Participant must be able to provide a newly obtained or archival tissue sample.
* Participant must have adequate organ and bone marrow function, per laboratory test results prior to Rina-S administration.
Key Exclusion Criteria (all study cohorts):
* Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea \> grade 1, ulcerative colitis, inflammatory bowel disease.
* Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or recent perforation (within 4 to 6 weeks).
* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy.
* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease).
* Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC).
* Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 6 October 2026.
- This page last checked by Voxsanity: 13 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.