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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Cachexia
• Intervention / Treatment: Drug: DS010 injection; Drug: DS010 injection

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rock Xie; Phone Number: 86-15805177049; Email: xiez@dartsbio.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
      • Principal Investigator: Li Zhang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS010 dose level 1	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 dose level 2	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 dose level 3	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 dose level 4	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 dose level 5	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 dose level 6	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 expansion 1	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 expansion 2	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 expansion 3	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection
Experimental: DS010 expansion 4	Drug: DS010 injection; Once every 3 weeks intravenously injection; Drug: DS010 injection; Once every 3 weeks or once every 4 weeks intravenously injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)		From the first dose to week 12
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)		From the first dose to week 12
Serum concentrations of total GDF-15		Baseline, week 12
Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline		Baseline, week 12
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline	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.	Baseline, week 12
Changes in Patient Global Impression of Severity (PGI-S) from baseline	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.	Baseline, week 12
Changes in Patient Global Impression of Change (PGI-C) from baseline	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.	Baseline, week 12
Changes in appetite visual analogue scale (VAS) score from baseline	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.	Baseline, week 12

Collaborators and Investigators

• Sponsor: Dartsbio Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Cachexia
• Other Study ID Numbers: DS010-01-1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No