Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
NCT07921576, Phase 1, Phase 2, Recruiting, Dartsbio Pharmaceuticals Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia | ClinicalTrials.gov |
| NCT number | NCT07921576 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 58 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Dartsbio Pharmaceuticals Ltd. | ClinicalTrials.gov |
| Conditions | Cancer, Cachexia | ClinicalTrials.gov |
| Interventions | DS010 injection | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Phase 1: Dose-limiting toxicity (DLT) | 21 days after the first dose | ClinicalTrials.gov | |
| Primary | Phase 1: Incidence of adverse events as assessed by CTCAE V6.0 | Up to 20 weeks | ClinicalTrials.gov | |
| Primary | Phase 2: Change in body weight from baseline to Week 12 | Baseline, Week 12 | ClinicalTrials.gov | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | From the first dose to week 12 | ClinicalTrials.gov | |
| Secondary | Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable) | From the first dose to week 12 | ClinicalTrials.gov | |
| Secondary | Serum concentrations of total GDF-15 | Baseline, week 12 | ClinicalTrials.gov | |
| Secondary | Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline | Baseline, week 12 | ClinicalTrials.gov | |
| Secondary | Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in Patient Global Impression of Severity (PGI-S) from baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in Patient Global Impression of Change (PGI-C) from baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in appetite visual analogue scale (VAS) score from baseline | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)