Cancer Cachexia
Conditions
Keywords
cachexia, cancer, GDF-15, IL-6
Brief summary
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.
Interventions
DRUGGFS202A injection
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Sponsors
Genfleet Therapeutics (Shanghai) Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in the study and sign the informed consent form. 2. Men or women between the ages of 18 and 80 years at the time of written informed consent. 3. Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI \< 21 kg/m2 within 6 months before the first study dose. 4. Persistent concomitant appetite/eating problems related to cancer. 5. It has adequate organ function. 6. The ECOG PS score was 0-2. 7. The investigator judged the expected survival time to be ≥ 3 months.
Exclusion criteria
1. With active brain metastases. 2. With other active diseases that lead to reduced food intake or seriously affect digestion and absorption 3. Baseline BMI \> 28 kg/m2. 4. With infectious diseases. 5. With clinically significant cardiovascular disease. 6. With uncontrolled metabolic diseases. 7. With known clinically significant allergic reactions to antibodies and excipients. 8. With history of drug or alcohol abuse. 9. Pregnant or lactating female subjects or women planning to become pregnant during the study. 10. With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month). 11. Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
China
Contacts
Primary ContactYuting Peng, PM
Outcome results
None listed