Not yet recruiting NCT07530666
Study of the Safety and Efficacy of DS010 in Patients With Cancer Cachexia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DS010 injection, DS010 injection, DS010 injection, DS010 injection.
- Who it may be relevant to
- Registry conditions: Cancer, Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase I/II Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of DS010 in Patients With Cancer Cachexia
Overview
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
Interventions
- Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks or once every 4 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks or once every 4 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks or once every 4 weeks intravenously injection - Drug DS010 injection
Once every 3 weeks or once every 4 weeks intravenously injection
Primary outcome measures
- Phase 1: Dose-limiting toxicity (DLT) [Time frame: 21 days after the first dose]
- Phase 1: Incidence of adverse events as assessed by CTCAE V6.0 [Time frame: Up to 20 weeks]
- Phase 2: Change in body weight from baseline to Week 12 [Time frame: Baseline, Week 12]
Secondary outcome measures (8)
- Maximum Observed Plasma Concentration (Cmax) [Time frame: From the first dose to week 12]
- Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable) [Time frame: From the first dose to week 12]
- Serum concentrations of total GDF-15 [Time frame: Baseline, week 12]
- Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline [Time frame: Baseline, week 12]
- Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline [Time frame: Baseline, week 12]
- Changes in Patient Global Impression of Severity (PGI-S) from baseline [Time frame: Baseline, week 12]
- Changes in Patient Global Impression of Change (PGI-C) from baseline [Time frame: Baseline, week 12]
- Changes in appetite visual analogue scale (VAS) score from baseline [Time frame: Baseline, week 12]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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 ;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07530666 · DS010-01-1102