DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks intravenously injection
DS010 injection: Once every 3 weeks or once every 4 weeks intravenously injection
DS010 injection: Once every 3 weeks or once every 4 weeks intravenously injection
DS010 injection: Once every 3 weeks or once every 4 weeks intravenously injection
DS010 injection: Once every 3 weeks or once every 4 weeks intravenously injection
Study summary
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 ;
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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