A Phase 1 interventional study of GFS202A injection in Cancer Cachexia, sponsored by Genfleet Therapeutics (Shanghai) Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 29 studies in Cachexia with a site in China — 22 open to participants now, 22 under way, 2 of them phase 3. Cachexia · China.
Among the 29 studies in Cachexia with a site in China, this one is the 19th largest by planned enrollment of the 22 interventional ones that give a count, is one of 8 that started in 2025, is one of 7 in phase 1, reaches primary completion later than 4 of the 21 other live ones, and was the 10th registered.
331 studies on the registry are indexed under Cachexia; 74 are open to participants now.
Browse Cachexia studies →22 of the 29 studies in Cachexia with a site in China are open now. Recruiting first, the newest first:
Qilu Pharmaceutical Co., Ltd. · Sites in China
Ages 18–55 · Healthy volunteers
Kexing Biopharm Co., Ltd. · Sites in China
Ages 18+
Second Xiangya Hospital of Central South University · Sites in China
Ages 18+ · Women only
Peking Union Medical College Hospital · Sites in China
Ages 18+
China Medical University, China · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 55 Cachexia studies recruiting now, 32 (58%) set no upper age limit and 14 (25%) stop at 75 or younger; 7 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 8 · Phase 3 2 · Phase 4 2
First in 2007; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 36 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Median enrollment 88 across the 22 interventional studies, 150 across the 7 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 29 have an industry lead sponsor. The 10 most frequent:
Genfleet Therapeutics (Shanghai) Inc. is the lead sponsor of 18 studies on the registry; 14 are open to participants now.
Genfleet Therapeutics (Shanghai) Inc. has 1 study filed under Cachexia — fewer than ten, so there is no comparison to draw.
9 of the studies in Cachexia with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07356037Phase 3Changchun GeneScience Pharmaceutical Co., Ltd.Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma | 2027-06-30 |
| NCT07338487Second Xiangya Hospital of Central South UniversityA Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer | 2026-12-01 |
| NCT07185308Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPostbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer | 2026-12-31 |
| NCT07243379Changchun GeneScience Pharmaceutical Co., Ltd.A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia | 2026-12-31 |
| NCT07890324Jiangsu Guiqiong Pharmaceutical Co., Ltd.A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia | 2027-08 |
Add all 9 to your calendar (.ics) → With an account.
Among the 29 studies in Cachexia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GFS202A injection
Drug: GFS202A injection
Drug: GFS202A injection
Drug: GFS202A injection
Drug: GFS202A injection
Drug: GFS202A injection
Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2026, 13 months after the start.
Of 21 phase 1 interventional studies under Cachexia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 13 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genfleet Therapeutics (Shanghai) Inc. →