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

ConditionsCancerCachexia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartsbio Pharmaceuticals Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Sequential

Treatments tested in this trial

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks or once every 4 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks or once every 4 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks or once every 4 weeks intravenously injection

  • DS010 injection

    Drug

    Once every 3 weeks or once every 4 weeks intravenously injection

Treatment groups

58 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: DS010 dose level 1Experimental treatment 1 intervention
Group B: DS010 dose level 2Experimental treatment 1 intervention
Group C: DS010 dose level 3Experimental treatment 1 intervention
Group D: DS010 dose level 4Experimental treatment 1 intervention
Group E: DS010 dose level 5Experimental treatment 1 intervention
Group F: DS010 dose level 6Experimental treatment 1 intervention
Group G: DS010 expansion 1Experimental treatment 1 intervention
Group H: DS010 expansion 2Experimental treatment 1 intervention
Group I: DS010 expansion 3Experimental treatment 1 intervention
Group J: DS010 expansion 4Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartsbio Pharmaceuticals Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: