Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia

November 2, 2026 updated by: Dartsbio Pharmaceuticals Ltd.

A Phase 1/2, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of DS010 as Single Agent in Patients With Advanced Cancer and Cachexia

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Concord West, New South Wales, Australia, 2138
        • Recruiting
        • Concord Cancer Centre Medical Oncology Clinical Trials Unit
        • Contact:
        • Principal Investigator:
          • Tam Bui Kim
      • Frenchs Forest, New South Wales, Australia, 2086
        • Recruiting
        • Cancer Care Northern Beache
        • Contact:
        • Principal Investigator:
          • Paul De Souza
      • Miranda, New South Wales, Australia, 2228
        • Recruiting
        • Southside Cancer Care Centre
        • Contact:
        • Principal Investigator:
          • Mahmood Alam
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula and Southeast Oncology (PASO)
        • Principal Investigator:
          • Vinod Ganju
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DS010 dose level 1
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 dose level 2
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 dose level 3
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 dose level 4
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 dose level 5
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 dose level 6
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 expansion 1
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 expansion 2
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 expansion 3
Drug: DS010 injection

Once every 3 weeks intravenously injection
Experimental: DS010 expansion 4
Drug: DS010 injection

Once every 3 weeks intravenously injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Phase 1: Dose-limiting toxicity (DLT)
Time Frame: 21 days after the first dose
21 days after the first dose
Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
Time Frame: Up to 20 weeks
Up to 20 weeks
Phase 2: Change in body weight from baseline to Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: From the first dose to week 12
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
From the first dose to week 12
Serum concentrations of total GDF-15
Time Frame: Baseline, week 12
Baseline, week 12
Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline
Time Frame: Baseline, week 12
Baseline, week 12
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.
Baseline, week 12
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.
Baseline, week 12
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.
Baseline, week 12
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.
Baseline, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartsbio Pharmaceuticals Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul De Souza, Cancer Care Northern Beache
  • Principal Investigator: Vinod Ganju, Peninsula and Southeast Oncology (PASO)
  • Principal Investigator: Tam Bui Kim, Concord Cancer Centre Medical Oncology Clinical Trials Unit
  • Principal Investigator: Mahmood Alam, Southside Cancer Care Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS010-02-1101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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