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 CStone Pharmaceuticals
Registry number NCT07622524
Started 16 July 2026 Today 16 October 2026 Estimated completion 1 January 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
St Vincent's Hospital Sydney Darlinghurst NSW Not yet recruiting
Macquarie University North Ryde NSW Recruiting
Calvary Mater Newcastle Waratah NSW Recruiting
Icon Cancer Centre South Brisbane South Brisbane QLD Recruiting
St Vincent's Hospital Melbourne Fitzroy VIC Not yet recruiting
Linear Clinical Research Ltd Nedlands WA 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 310

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:

* Evidence of a personally signed and dated informed consent document.

* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

* Being ≥ 18 years of age on the day of signing informed consent.

* Pathologically or cytologically confirmed, unresectable advanced solid tumors.

* Participants must have at least one measurable lesion according to RECIST Version1.1.

* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

* Adequate organ function.

* Life expectancy ≥ 3 months.

* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration

Exclusion Criteria:

* Has disease that is suitable for local treatment administered with curative intent.

* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.

* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.

* Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.

* Has uncontrolled pleural effusion, pericardial effusion, or ascites.

* Has immune deficient disease or received systemic immunosuppressive treatment.

* Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.

* Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids.

* Has active infections requiring systemic therapy.

* Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.

* Insufficient washout from prior anti-tumor therapy.

* Received live vaccine within 28 days prior to first dose.

* History of allogeneic organ or hematopoietic stem cell transplantation.

* History of hypersensitivity to excipients of study drug or any monoclonal antibody.

* Any toxic effects of prior therapy unresolved to Grade ≤1.

* Active alcohol or drug abuse.

* Pregnant or breastfeeding women.

* Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.

Dates on the record

Started 16 July 2026
Estimated completion 1 January 2028
Registry last updated 14 August 2026
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: 14 August 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.