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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07921576




Registration number
Help: Registration number
NCT07921576
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
2/11/2026
Date registered
Help: Date registered
6/11/2026
Date last updated
Help: Date last updated
6/11/2026

Titles & IDs
Public title
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Scientific 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
Additional trial identifiers [1] 0 0
DS010-02-1101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Cancer 0 0
Cachexia 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - DS010 injection

Experimental: DS010 dose level 1 -

Experimental: DS010 dose level 2 -

Experimental: DS010 dose level 3 -

Experimental: DS010 dose level 4 -

Experimental: DS010 dose level 5 -

Experimental: DS010 dose level 6 -

Experimental: DS010 expansion 1 -

Experimental: DS010 expansion 2 -

Experimental: DS010 expansion 3 -

Experimental: DS010 expansion 4 -


Treatment: Drugs: DS010 injection
Once every 3 weeks intravenously injection
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Dose-limiting toxicity (DLT)
Timepoint [1] 0 0
21 days after the first dose
Primary outcome [2] 0 0
Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
Timepoint [2] 0 0
Up to 20 weeks
Primary outcome [3] 0 0
Phase 2: Change in body weight from baseline to Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
From the first dose to week 12
Secondary outcome [2] 0 0
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)
Timepoint [2] 0 0
From the first dose to week 12
Secondary outcome [3] 0 0
Serum concentrations of total GDF-15
Timepoint [3] 0 0
Baseline, week 12
Secondary outcome [4] 0 0
Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline
Timepoint [4] 0 0
Baseline, week 12
Secondary outcome [5] 0 0
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline
Timepoint [5] 0 0
Baseline, week 12
Secondary outcome [6] 0 0
Changes in Patient Global Impression of Severity (PGI-S) from baseline
Timepoint [6] 0 0
Baseline, week 12
Secondary outcome [7] 0 0
Changes in Patient Global Impression of Change (PGI-C) from baseline
Timepoint [7] 0 0
Baseline, week 12
Secondary outcome [8] 0 0
Changes in appetite visual analogue scale (VAS) score from baseline
Timepoint [8] 0 0
Baseline, week 12

Eligibility
Key inclusion criteria
* Key

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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Key

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 ;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2028
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Cancer Centre Medical Oncology Clinical Trials Unit - Concord West
Recruitment hospital [2] 0 0
Cancer Care Northern Beache - Frenchs Forest
Recruitment hospital [3] 0 0
Southside Cancer Care Centre - Miranda
Recruitment hospital [4] 0 0
Peninsula and Southeast Oncology (PASO) - Frankston
Recruitment postcode(s) [1] 0 0
2138 - Concord West
Recruitment postcode(s) [2] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dartsbio Pharmaceuticals Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul De Souza
Address 0 0
Cancer Care Northern Beache
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lingyan Chen
Address 0 0
Country 0 0
Phone 0 0
+86 13816915728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07921576