NCT06898255

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Apr 2025Jul 2026

First Submitted

Initial submission to the registry

March 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2026

Last Updated

June 5, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 14, 2025

Last Update Submit

June 3, 2025

Conditions

Cancer Cachexia

Keywords

cachexiacancerGDF-15IL-6

Outcome Measures

Primary Outcomes (2)

  • Incidence of AE/SAE

    Up to 6 weeks after the last dose

  • Incidence of DLT

    Up to 21 days after the first dose

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (6)

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

Interventions

GFS202A injectionDRUG

Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.

GFS202A dose level 1GFS202A dose level 2GFS202A dose level 3GFS202A dose level 4GFS202A dose level 5GFS202A dose level 6

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun-Yat Sen university cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

CachexiaNeoplasms

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Li Zhang, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuting Peng, PM

CONTACT

86+13730813620ytpeng@genfleet.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 27, 2025

Study Start

April 24, 2025

Primary Completion (Estimated)

June 8, 2026

Study Completion (Estimated)

July 6, 2026

Last Updated

June 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)