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NCT05858736

NCT05858736
Active, Not Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be 18 years of age or older at the time of signing the consent form.
  • People of all genders may apply; however, women who could become pregnant must have a negative pregnancy test before joining.
  • You must be well enough to carry out light daily activities, based on a standard health performance scale (ECOG score of 0 or 1).
  • You must have been diagnosed with a solid tumour (confirmed by a tissue or cell sample) that has spread or cannot be removed by surgery, and is continuing to grow.
  • Your cancer must be measurable by a CT scan or chest X-ray, meaning at least one tumour or lymph node meets specific size requirements as judged by your medical team.
  • Your liver, kidneys, and other organs must be working well enough, based on blood test results meeting specific levels set by the trial.
  • You must be willing to take part and sign a written consent form.
  • Both female and male participants must agree to use contraception as required by the trial.
  • You must be expected to live for at least 12 weeks or more.

Who may not be able to join:

  • You may not be eligible if you are still experiencing significant side effects from previous cancer treatments that have not sufficiently recovered (confirm with trial site for exact grade thresholds).
  • You must have finished certain previous cancer treatments within a set period before joining — for example, chemotherapy or radiation at least 21 days before, and antibody-based therapies at least 28 days before.
  • You cannot currently be enrolled in another clinical trial testing an experimental treatment, or be receiving other cancer treatments at the same time.
  • You cannot be taking steroid medicines (such as prednisone) at doses higher than 10 mg per day within 7 days before starting the trial.
  • You cannot have active cancer that has spread to the brain or the lining around the brain and spinal cord.
  • You cannot have an active infection that requires antibiotic treatment given through a drip (IV) within 14 days before starting the trial (routine treatment for urinary tract infections or topical treatments are generally allowed).
  • You may not be eligible if the trial doctor believes your medical history, current health, or test results could affect the trial results or put you at risk.
  • You may not be eligible if you have a psychiatric condition or substance use problem that the doctor believes would make it difficult for you to follow the trial requirements.
  • You cannot join if you are currently pregnant or breastfeeding.
  • You cannot join if you have an active autoimmune disease that requires stronger immune-suppressing treatment than 10 mg per day of prednisone, or if you have inflammatory bowel disease or myasthenia gravis.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 1
Sponsor
OncoC4, Inc.
Registry
clinicaltrials_gov
Start date
11 July 2023
Est. completion
31 July 2026

Where this trial is recruiting

🇦🇺 Australia

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Dose Limiting Toxicity (DLT); Maximum Toxicity Dose (MTD); Recommended Phase II Dose (RP2D); Incidence of treatment emergent adverse events (TEAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov