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A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS010 dose level 1 | Experimental |
| |
| DS010 dose level 2 | Experimental |
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| DS010 dose level 3 | Experimental |
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| DS010 dose level 4 | Experimental |
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| DS010 dose level 5 | Experimental |
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| DS010 dose level 6 | Experimental |
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| DS010 expansion 1 | Experimental |
| |
| DS010 expansion 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS010 injection | Drug | Once every 3 weeks intravenously injection |
| |
| Measure | Description | 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rock Xie | Contact | 86-15805177049 | xiez@dartsbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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|
| DS010 expansion 3 | Experimental |
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| DS010 expansion 4 | Experimental |
|
| 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 |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
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