Phase 1 study

Recruiting Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 1
Sponsor Anwita Biosciences
Registry number NCT06092580
Started 15 September 2023 Today 16 October 2026 Estimated completion 30 June 2026

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
ICON Cancer Center South Brisbane South Brisbane QLD Recruiting
Southern Oncology Clinical Research Unit (SOCRU) Bedford Park SA Recruiting
Monash Medical Centre Clayton VIC Recruiting
Alfred Health Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 60

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:

* Subject has provided informed consent prior to initiation of any study specific activities or procedures.

* Subject must be ≥ 18 years of age or per local regulation.

* Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy. Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available.

* Subject must have performance status of 0, or 1 on the ECOG performance scale.

* Subject with adequate organ function.

* Life expectancy is longer than three months.

* Subject must be able to receive effective contraceptive measures.

Exclusion Criteria:

* Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy.

* Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities.

* Subject is receiving other investigational agent or device.

* Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%.

* Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant.

* Subject has active central nervous system (CNS) metastases or carcinomatous meningitis.

* Subject with HIV whose viral load is \> 400 copies/mL or CD4+ T cell counts are \< 350 cells/µL.

* Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula.

* Subject is pregnant or breast-feeding.

* Subject has received live virus vaccine within 28 days prior to the first dose of study.

* Any other conditions that might compromise the safety of the subject or the integrity of the study.

Dates on the record

Started 15 September 2023
Estimated completion 30 June 2026
Registry last updated 2 September 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 2 September 2025.
  • 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.