CancerPhase 1/2NCT07921576
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
A Phase 1/2 study testing DS010 injection in people with Cancer and Cachexia, run by Dartsbio Pharmaceuticals Ltd. at 4 sites in Australia.
Trial summary
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- DS010 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesAustralia
- Study dates
- 30 Nov 2026to 15 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥ 18 years at screening;
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Able to provide written informed consent;
- ECOG performance status score of 0, 1, or 2;
- Patients with histologically or cytologically confirmed malignant solid tumor;
- Cancer cachexia documented in medical records;
Who cannot join
- History of hypersensitivity or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules composed of monoclonal antibody components;
- Presence of reversible decreased food intake, as determined by the investigator;
- Receiving tube feeding or parenteral nutrition (total or partial parenteral nutrition) at screening;
- Severe gastrointestinal disorders (including esophagitis, gastritis, malabsorption);
- Cachexia caused by other reasons;
- Currently participating in another investigational drug study, or receipt of another investigational product ;
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Recruiting
Concord Cancer Centre Medical Oncology Clinical Trials Unit
Concord West, New South Wales, 2138
Tam Bui Kim, +61 04 5906 4548, Tam.bui@health.nsw.gov.au
Tam Bui Kim
- Recruiting
Peninsula and Southeast Oncology (PASO)
Frankston, Victoria, 3199
Vinod Ganju, +61 03 9781 5244, vg@paso.com.au
Vinod Ganju
- Recruiting
Cancer Care Northern Beache
Frenchs Forest, New South Wales, 2086
Paul De Souza, +61 02 8357 5261, pdesouza@canopycr.com.au
Paul De Souza
- Recruiting
Southside Cancer Care Centre
Miranda, New South Wales, 2228
Mahmood Alam, +61 02 8556 9300, malam@cancercarefoundation.org.au
Mahmood Alam
About this study
Official title: A Phase 1/2, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of DS010 as Single Agent in Patients With Advanced Cancer and Cachexia
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
- Being tested
- DS010 injection
- Medical subject headings
- Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS010 injectionDrug
Once every 3 weeks intravenously injection
| Study group | Role | What they receive |
|---|---|---|
| DS010 dose level 1 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 dose level 2 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 dose level 3 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 dose level 4 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 dose level 5 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 dose level 6 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 expansion 1 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 expansion 2 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 expansion 3 | Experimental | Not described Receives: Drug: DS010 injection |
| DS010 expansion 4 | Experimental | Not described Receives: Drug: DS010 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose-limiting toxicity (DLT)
Measured: 21 days after the first dose
Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
Measured: Up to 20 weeks
Phase 2: Change in body weight from baseline to Week 12
Measured: Baseline, Week 12
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Measured: From the first dose to week 12
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)
Measured: From the first dose to week 12
Serum concentrations of total GDF-15
Measured: Baseline, week 12
Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion16 Jun 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartsbio Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul De Souza, Principal investigator, Cancer Care Northern BeacheVinod Ganju, Principal investigator, Peninsula and Southeast Oncology (PASO)Tam Bui Kim, Principal investigator, Concord Cancer Centre Medical Oncology Clinical Trials UnitMahmood Alam, Principal investigator, Southside Cancer Care Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921576
- Sponsor's protocol ID
- DS010-02-1101
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of DS010 as Single Agent in Patients With Advanced Cancer and Cachexia
- ClinicalTrials.gov ID
- NCT07921576
- Acronym / sponsor ID
- DS010-02-1101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Dartsbio Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| DS010 dose level 1 | Experimental | Drug: DS010 injection |
| DS010 dose level 2 | Experimental | Drug: DS010 injection |
| DS010 dose level 3 | Experimental | Drug: DS010 injection |
| DS010 dose level 4 | Experimental | Drug: DS010 injection |
| DS010 dose level 5 | Experimental | Drug: DS010 injection |
| DS010 dose level 6 | Experimental | Drug: DS010 injection |
| DS010 expansion 1 | Experimental | Drug: DS010 injection |
| DS010 expansion 2 | Experimental | Drug: DS010 injection |
| DS010 expansion 3 | Experimental | Drug: DS010 injection |
| DS010 expansion 4 | Experimental | Drug: DS010 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS010 injectionOnce every 3 weeks intravenously injection | Drug | DS010 dose level 1, DS010 dose level 2, DS010 dose level 3, DS010 dose level 4, DS010 dose level 5, DS010 dose level 6, DS010 expansion 1, DS010 expansion 2, DS010 expansion 3, DS010 expansion 4 |
Primary outcome
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
8 secondary outcomes
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
Time frame: Baseline, week 12
Changes in Patient Global Impression of Severity (PGI-S) from baseline
Time frame: Baseline, week 12
Changes in Patient Global Impression of Change (PGI-C) from baseline
Time frame: Baseline, week 12
Changes in appetite visual analogue scale (VAS) score from baseline
Time frame: Baseline, week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul De Souza principal investigator
Cancer Care Northern Beache
Vinod Ganju principal investigator
Peninsula and Southeast Oncology (PASO)
Tam Bui Kim principal investigator
Concord Cancer Centre Medical Oncology Clinical Trials Unit
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DS010 injection in people with Cancer and Cachexia, run by Dartsbio Pharmaceuticals Ltd. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyan Chen (+86 13816915728, chenlingyan@dartsbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Dose-limiting toxicity (DLT) (time frame: 21 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.