Cancer CachexiaPhase 1NCT06898255
A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
A Phase 1 study testing GFS202A injection in people with Cancer Cachexia, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- GFS202A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to 6 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent form.
- Men or women between the ages of 18 and 80 years at the time of written informed consent.
- 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.
- Persistent concomitant appetite/eating problems related to cancer.
- It has adequate organ function.
- The ECOG PS score was 0-2.
- The investigator judged the expected survival time to be ≥ 3 months.
Who cannot join
- With active brain metastases.
- With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
- Baseline BMI > 28 kg/m2.
- With infectious diseases.
- With clinically significant cardiovascular disease.
- With uncontrolled metabolic diseases.
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- With known clinically significant allergic reactions to antibodies and excipients.
- With history of drug or alcohol abuse.
- Pregnant or lactating female subjects or women planning to become pregnant during the study.
- With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun-Yat Sen university cancer center
Guangzhou, Guangdong, 510000
Li Zhang, MD, 020-87343533, zhangli@syscc.org.cn
About this study
Official title: 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
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.
- Conditions
- Cancer Cachexia
- Being tested
- GFS202A injection
- Keywords
- cachexia, cancer, GDF-15, IL-6
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFS202A injectionDrug
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GFS202A dose level 1 | Experimental | Not described Receives: Drug: GFS202A injection |
| GFS202A dose level 2 | Experimental | Not described Receives: Drug: GFS202A injection |
| GFS202A dose level 3 | Experimental | Not described Receives: Drug: GFS202A injection |
| GFS202A dose level 4 | Experimental | Not described Receives: Drug: GFS202A injection |
| GFS202A dose level 5 | Experimental | Not described Receives: Drug: GFS202A injection |
| GFS202A dose level 6 | Experimental | Not described Receives: Drug: GFS202A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE/SAE
Measured: Up to 6 weeks after the last dose
Incidence of DLT
Measured: Up to 21 days after the first dose
Secondary outcomes (10)
Peak Plasma Concentration (Cmax)
Measured: Baseline, up to 6 weeks after the last dose
Area under the plasma concentration versus time curve (AUC)
Measured: Baseline, up to 6 weeks after the last dose
Trough Plasma Concentration (Ctrough)
Measured: Baseline, up to 6 weeks after the last dose
Half-life (T1/2)
Measured: Baseline, up to 6 weeks after the last dose
Incidence of ADA
Measured: Baseline, up to 6 weeks after the last dose
Concentration of GDF-15 and IL-6
Measured: Baseline, up to 6 weeks after the last dose
Weight change from baseline
Measured: Baseline, up to 6 weeks after the last dose
L3SMI change from baseline
Measured: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) scores
Measured: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Cancer Therapy-General (FACT-G) scores
Measured: Baseline, up to 6 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start24 Apr 2025
- Primary completion8 Jun 2026 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898255
- Sponsor's protocol ID
- GFS202AX1101
- Other IDs
- CXSL2400937
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06898255
- Acronym / sponsor ID
- GFS202AX1101
- Conditions
- Cancer Cachexia
- Keywords
- cachexia, cancer, GDF-15, IL-6
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GFS202A dose level 1 | Experimental | Drug: GFS202A injection |
| GFS202A dose level 2 | Experimental | Drug: GFS202A injection |
| GFS202A dose level 3 | Experimental | Drug: GFS202A injection |
| GFS202A dose level 4 | Experimental | Drug: GFS202A injection |
| GFS202A dose level 5 | Experimental | Drug: GFS202A injection |
| GFS202A dose level 6 | Experimental | Drug: GFS202A injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in the study and sign the informed consent form.
- Men or women between the ages of 18 and 80 years at the time of written informed consent.
- 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.
- Persistent concomitant appetite/eating problems related to cancer.
- It has adequate organ function.
Key exclusion criteria (11 listed)
- With active brain metastases.
- With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
- Baseline BMI > 28 kg/m2.
- With infectious diseases.
- With clinically significant cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFS202A injectionParticipants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks. | Drug | GFS202A dose level 1, GFS202A dose level 2, GFS202A dose level 3, GFS202A dose level 4, GFS202A dose level 5, GFS202A dose level 6 |
Primary outcome
Incidence of AE/SAE
Time frame: Up to 6 weeks after the last dose
Incidence of DLT
Time frame: Up to 21 days after the first dose
10 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Baseline, up to 6 weeks after the last dose
Area under the plasma concentration versus time curve (AUC)
Time frame: Baseline, up to 6 weeks after the last dose
Trough Plasma Concentration (Ctrough)
Time frame: Baseline, up to 6 weeks after the last dose
Half-life (T1/2)
Time frame: Baseline, up to 6 weeks after the last dose
Incidence of ADA
Time frame: Baseline, up to 6 weeks after the last dose
Concentration of GDF-15 and IL-6
Time frame: Baseline, up to 6 weeks after the last dose
Weight change from baseline
Time frame: Baseline, up to 6 weeks after the last dose
L3SMI change from baseline
Time frame: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) scores
Time frame: Baseline, up to 6 weeks after the last dose
Change from baseline in Functional Assessment of Cancer Therapy-General (FACT-G) scores
Time frame: Baseline, up to 6 weeks after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GFS202A injection in people with Cancer Cachexia, run by Genfleet Therapeutics (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Peng, PM (86+13730813620, ytpeng@genfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE/SAE (time frame: Up to 6 weeks after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.