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| ID | Type | Description | Link |
|---|---|---|---|
| CXSL2400937 | Other Identifier | NMPA |
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An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.
Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFS202A dose level 1 | Experimental |
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| GFS202A dose level 2 | Experimental |
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| GFS202A dose level 3 | Experimental |
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| GFS202A dose level 4 | Experimental |
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| GFS202A dose level 5 | Experimental |
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| GFS202A dose level 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFS202A injection | Drug | Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE/SAE | Up to 6 weeks after the last dose | |
| Incidence of DLT | Up to 21 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Baseline, up to 6 weeks after the last dose | |
| Area under the plasma concentration versus time curve (AUC) | Baseline, up to 6 weeks after the last dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuting Peng, PM | Contact | 86+13730813620 | ytpeng@genfleet.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun-Yat Sen university cancer center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| Trough Plasma Concentration (Ctrough) |
| Baseline, up to 6 weeks after the last dose |
| Half-life (T1/2) | Baseline, up to 6 weeks after the last dose |
| Incidence of ADA | Baseline, up to 6 weeks after the last dose |
| Concentration of GDF-15 and IL-6 | Baseline, up to 6 weeks after the last dose |
| Weight change from baseline | Baseline, up to 6 weeks after the last dose |
| L3SMI change from baseline | Baseline, up to 6 weeks after the last dose |
| Change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) scores | Baseline, up to 6 weeks after the last dose |
| Change from baseline in Functional Assessment of Cancer Therapy-General (FACT-G) scores | Baseline, up to 6 weeks after the last dose |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |