DS010 in advanced cancer with cachexia: safety and early signals in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional trial evaluating DS010 injections in adults with histologically confirmed solid tumors and cancer cachexia. The study aims to assess safety and tolerability and gather preliminary signs of efficacy. Eligible participants are adults 18 and older with an ECOG score of 0–2 and documented cachexia who can comply with visits and procedures. Key exclusions include severe GI disorders, certain nutritional needs, and prior hypersensitivity to antibody-based therapies. The trial is led by Dartsbio Pharmaceuticals Ltd. with sites in New South Wales, Australia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Key Inclusion Criteria:

  1. Subjects aged ≥ 18 years at screening;
  2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
  3. Able to provide written informed consent;
  4. ECOG performance status score of 0, 1, or 2;
  5. Patients with histologically or cytologically confirmed malignant solid tumor;
  6. Cancer cachexia documented in medical records;

Exclusion Criteria:

* Key Exclusion Criteria:

  1. History of hypersensitivity or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules composed of monoclonal antibody components;
  2. Presence of reversible decreased food intake, as determined by the investigator;
  3. Receiving tube feeding or parenteral nutrition (total or partial parenteral nutrition) at screening;
  4. Severe gastrointestinal disorders (including esophagitis, gastritis, malabsorption);
  5. Cachexia caused by other reasons;
  6. Currently participating in another investigational drug study, or receipt of another investigational product ;

Where it's running

• Concord Cancer Centre Medical Oncology Clinical Trials Unit
  Concord West, New South Wales, Australia Recruiting
• Cancer Care Northern Beache
  Frenchs Forest, New South Wales, Australia Recruiting
• Southside Cancer Care Centre
  Miranda, New South Wales, Australia Recruiting
• Peninsula and Southeast Oncology (PASO)
  Frankston, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Paul De Souza — Cancer Care Northern Beache
• Study coordinator: Lingyan Chen
• Email: chenlingyan@dartsbio.com
• Phone: +86 13816915728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.