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

NCT07530666 | Not Yet Recruiting Phase 1

• 1 other identifier: DS010-01-1102
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Cachexia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

  Baseline, week 12

Study Arms (10)

DS010 dose level 1

EXPERIMENTAL

Drug: DS010 injection

DS010 dose level 2

EXPERIMENTAL

Drug: DS010 injection

DS010 dose level 3

EXPERIMENTAL

Drug: DS010 injection

DS010 dose level 4

EXPERIMENTAL

Drug: DS010 injection

DS010 dose level 5

EXPERIMENTAL

Drug: DS010 injection

DS010 dose level 6

EXPERIMENTAL

Drug: DS010 injection

DS010 expansion 1

EXPERIMENTAL

Drug: DS010 injection

DS010 expansion 2

EXPERIMENTAL

Drug: DS010 injection

DS010 expansion 3

EXPERIMENTAL

Drug: DS010 injection

DS010 expansion 4

EXPERIMENTAL

Drug: DS010 injection

Interventions

DS010 injection DRUG

Once every 3 weeks intravenously injection

DS010 dose level 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Dartsbio Pharmaceuticals Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

Rock Xie

CONTACT

86-15805177049; xiez@dartsbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)