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

Phase I/II Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of DS010 in Patients With Cancer Cachexia

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

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 ;