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 Sun Pharma Advanced Research Company Limited
Registry number NCT07042100
Started 12 August 2025 Today 16 October 2026 Estimated completion 1 August 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Scientia Clinical Research Randwick NSW Recruiting
Sunshine Coast University Private Hospital Birtinya QLD Recruiting
Cancer Research South Australia Adelaide SA 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 177

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. Willing and able to give written and dated informed consent (or legally acceptable representative/ impartial witness when applicable) and is available for the entire study.

2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up.

3. Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no standard treatment is available.

4. Has a life expectancy of ≥3 months.

Exclusion Criteria:

1. Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.

2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.

3. Known or suspected history of significant drug abuse as judged by the Investigator.

4. Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.

5. Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.

6. Positive exclusion tests: urine pregnancy tests (if applicable), serology tests positive for HIV, HCV, HBsAg (unless they are considered subjects with resolved Hepatitis B and C infection).

7. History of any relevant allergy/ hypersensitivity including known immediate or delayed hypersensitivity reaction or idiosyncrasy to biological agents or drug chemically related to SBO-154 or its excipients.

8. Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.

Dates on the record

Started 12 August 2025
Estimated completion 1 August 2028
Registry last updated 28 July 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: 28 July 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.