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 |
|---|---|---|---|
| Sunshine Coast University Private Hospital | Sunshine Coast | Australia | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 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:
1. Aged ≥18 years, male or female.
2. Subjects with histologically or cytologically confirmed advanced solid tumors that are unresectable, who are refractory to or intolerant of or refuse all existing therapy(ies) known to provide clinical benefit for their condition.
3. At least one measurable lesion as assessed by RECIST 1.1.
4. ECOG performance status score of 0-1.
5. Estimated survival time of more than 3 months.
6. Adequate organ function.
7. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to first administration of the investigational drug. Females of childbearing potential must agree to abstain or use highly effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
8. Male subjects of reproductive capacity must agree to use effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
9. Subjects must be fully informed about this study before participation and must voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Receipt of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor therapy within 4 weeks prior to first dose of investigational drug.
2. Receipt of radiotherapy within 4 weeks prior to initiation of study treatment, or history of radiation pneumonitis.
3. Receipt of any other investigational drugs not yet marketed within 4 weeks prior to first dose of investigational drug.
4. Receipt of major organ surgery or occurrence of significant trauma, or requirement for elective surgery during the study, within 4 weeks prior to first dose of investigational drug.
5. Use of systemic glucocorticoids or other immunosuppressive agents within 14 days prior to the first dose of investigational drug or anticipated need during the study.
6. Use of immunomodulatory agents, including but not limited to thymosin, interleukin-2, interferons, etc., within 14 days prior to first administration of investigational drug.
7. Receipt of live vaccine or attenuated live vaccine within 4 weeks prior to first use of investigational drug. Inactivated vaccines are permitted.
8. History of prior allogeneic bone marrow transplantation or organ transplantation.
9. Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 based on CTCAE v5.0.
10. Subjects with central nervous system (CNS) metastasis.
11. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.
12. Known history of human immunodeficiency virus (HIV) positivity or history of acquired immunodeficiency syndrome (AIDS).
13. Subjects with active hepatitis B virus (HBV) infection.
14. History of other malignancies within the past 5 years.
15. History of severe cardiovascular or cerebrovascular disease.
16. Clinically significant severe pulmonary dysfunction.
17. Subjects with active or recurrent autoimmune diseases, or a related history and high risk for recurrence, or subjects at high risk.
18. Subjects with ulcerative keratitis, acute keratitis, or progressive keratitis.
19. Subjects with severe skin diseases.
20. Known hypersensitivity or allergy to any component of the investigational drug.
21. Prior receipt of immunotherapy, with severe immune-related toxicity regardless of remission status, as determined by the investigator to be unsuitable for immunotherapy.
22. Clinically uncontrolled pericardial, pleural, or peritoneal effusions requiring repeated drainage.
23. Dementia or altered mental status that may impair understanding and provision of informed consent form.
24. Pregnant or lactating females.
25. Underlying conditions.
26. Prior receipt of treatment with T cell engager drugs containing CD3 monoclonal antibodies.
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: 23 March 2026.
- This page last checked by Voxsanity: 11 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.