A Phase 1/2 interventional study of DS010 injection in Cancer and Cachexia, sponsored by Dartsbio Pharmaceuticals Ltd.. Recruiting at 4 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Dartsbio Pharmaceuticals Ltd. · Phase 1/2, Interventional, and Treatment
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Dartsbio Pharmaceuticals Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Key Inclusion Criteria:
Exclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Drug: DS010 injection
Once every 3 weeks intravenously injection
Phase 1: Dose-limiting toxicity (DLT)
Time frame: 21 days after the first dose
Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
Time frame: Up to 20 weeks
Phase 2: Change in body weight from baseline to Week 12
Time frame: Baseline, Week 12
Maximum Observed Plasma Concentration (Cmax)
Time frame: From the first dose to week 12
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)
Time frame: From the first dose to week 12
Serum concentrations of total GDF-15
Time frame: Baseline, week 12
Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline
Time frame: Baseline, week 12
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline
The total score is derived from the Functional Assessment of Cancer Therapy-General (FACT-G) plus the Anorexia/Cachexia Subscale (ACS). The FAACT total score ranges from 0 to 180, with higher scores indicating better quality of life and less severe anorexia/cachexia symptoms.
Time frame: Baseline, week 12
Changes in Patient Global Impression of Severity (PGI-S) from baseline
The PGI-S is a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater disease severity.
Time frame: Baseline, week 12
Changes in Patient Global Impression of Change (PGI-C) from baseline
The PGI-C is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate improvement, and higher scores indicate worsening of condition.
Time frame: Baseline, week 12
Changes in appetite visual analogue scale (VAS) score from baseline
The VAS scale ranges from 0 to 100 mm, where 0 indicates no appetite and 100 indicates the best possible appetite. Higher scores indicate better appetite.
Time frame: Baseline, week 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Dartsbio Pharmaceuticals Ltd.