A Phase I Study to Evaluate 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

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 Overview

• Status: Recruiting
• Conditions: Cancer Cachexia
• Intervention / Treatment: Drug: GFS202A injection

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuting Peng, PM; Phone Number: 86+13730813620; Email: ytpeng@genfleet.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun-Yat Sen University Cancer Center
      • Contact: li zhang, MD; Phone Number: 020-87343533; Email: zhangli@syscc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GFS202A dose level 1	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Experimental: GFS202A dose level 2	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Experimental: GFS202A dose level 3	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Experimental: GFS202A dose level 4	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Experimental: GFS202A dose level 5	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.
Experimental: GFS202A dose level 6	Drug: GFS202A injection; Participants will receive GFS202A intravenously every 3 weeks (Q3W) in a 21-day cycle. The treatment duration was 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Genfleet Therapeutics (Shanghai) Inc.
• Investigators: Principal Investigator: Li Zhang, MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): July 6, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cancer; IL-6; cachexia; GDF-15
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Body Weight; Body Weight Changes; Weight Loss; Thinness; Wasting Syndrome; Cachexia
• Other Study ID Numbers: GFS202AX1101; CXSL2400937 (Other Identifier: NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No