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NCT Number: NCT07530666

Study of the Safety and 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location contact

Li Zhang, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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;

Key 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 ;

Treatment and study plan

DS010 injection

Drug

Once every 3 weeks intravenously injection

Primary outcomes

  1. Phase 1: Dose-limiting toxicity (DLT)

    Time frame: 21 days after the first dose

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

    Time frame: Up to 20 weeks

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: From the first dose to week 12

  2. Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)

    Time frame: From the first dose to week 12

  3. Serum concentrations of total GDF-15

    Time frame: Baseline, week 12

  4. Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline

    Time frame: Baseline, week 12

  5. Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline

    Time frame: 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.

  6. Changes in Patient Global Impression of Severity (PGI-S) from baseline

    Time frame: 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.

  7. Changes in Patient Global Impression of Change (PGI-C) from baseline

    Time frame: 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.

  8. Changes in appetite visual analogue scale (VAS) score from baseline

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Dartsbio Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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