Cachexia, Cancer
Conditions
Brief summary
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
Interventions
DRUGDS010 injection
Once every 3 weeks intravenously injection
Sponsors
Dartsbio Pharmaceuticals Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; 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 ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Dose-limiting toxicity (DLT) | 21 days after the first dose |
| Phase 1: Incidence of adverse events as assessed by CTCAE V6.0 | Up to 20 weeks |
| Phase 2: Change in body weight from baseline to Week 12 | Baseline, Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | From the first dose to week 12 | — |
| Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable) | From the first dose to week 12 | — |
| Serum concentrations of total GDF-15 | Baseline, week 12 | — |
| Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline | Baseline, week 12 | — |
| Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline | Baseline, week 12 | 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. |
| Changes in Patient Global Impression of Severity (PGI-S) from baseline | Baseline, week 12 | 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. |
| Changes in Patient Global Impression of Change (PGI-C) from baseline | Baseline, week 12 | 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. |
| Changes in appetite visual analogue scale (VAS) score from baseline | Baseline, week 12 | 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. |
Countries
China
Contacts
CONTACTRock Xie
Outcome results
None listed