Phase 1 study for people with Colorectal Cancer
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Border Medical oncology - Albury Wodonga Regional Cancer Centre | Albury | NSW | Not yet recruiting |
| Calvary Mater Hospital Newcastle - Oncology | Waratah | NSW | Recruiting |
| Cabrini Health Oncology Research | Malvern | VIC | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 12 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.
Inclusion Criteria:
* KRAS G12D mutated solid tumor
* Participant must be ≥18 years old or the legal age of consent in the jurisdiction in which the study is taking place when signing the screening ICF
* At least one measurable lesion as per RECIST v1.1. outside the CNS
* Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1
* Male or Female: Contraceptive use by participant or participant's partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Life expectancy of at least 3 months in the opinion of the Investigator
* Histologically/pathologically documented diagnosis of advanced/metastatic adenocarcinoma of the colon and rectum.
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Leptomeningeal disease or carcinomatous meningiti
* Uncontrolled and/or active/symptomatic brain metastases.
* Significant traumatic injury or major surgical procedure within 4 weeks of first dose of study intervention
* Known hypersensitivity to any component of study intervention
* Previous (within 3 years) or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the respective substudy.
* Active infection requiring systemic anti-infective therapy within 14 days of first dose of study intervention
* Known HIV infection
* Active Hepatitis B virus (HBV) infection
* Active Hepatitis C virus (HCV) infection
* Significant cardiac disorder
* History of risk factors for torsade de pointes (TdP) (e.g., heart failure, family history of long QT syndrome)
* Participants with inadequately managed diabetes as assessed by the Investigator
* Toxicities from prior anticancer therapy, defined as not having resolved to Grade ≤1 or as specified in the respective substudy protocol as per NCI CTCAE v.6.0 with the following exceptions: Alopecia of any grade, Peripheral neuropathy Grade ≤2, Autoimmune endocrine disorders Grade ≤2 managed with stable endocrine replacement therapy
* History of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis (unless it has resolved without sequelae without use of steroids), or any evidence of clinically-active pneumonitis/ILD
* History of the following eye disorders: keratitis, ulcerative keratitis
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: 5 October 2026.
- This page last checked by Voxsanity: 12 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.