Not Yet RecruitingPhase 1/2

Study of the Safety and Efficacy of DS010 in Patients With Cancer Cachexia

China58 participantsStarted 2026-04-30

Plain-language summary

A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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 ;

Phase 1: Dose-limiting toxicity (DLT)

Timeframe: 21 days after the first dose

Phase 1: Incidence of adverse events as assessed by CTCAE V6.0

Timeframe: Up to 20 weeks

Phase 2: Change in body weight from baseline to Week 12

Timeframe: Baseline, Week 12

NCT IDNCT07530666

SponsorDartsbio Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-30

Rock Xie

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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 ;