GFS202A / GenFleet Therap - LARVOL DELTA

A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Genfleet Therapeutics (Shanghai) Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cachexia • Oncology • Solid Tumor

GFS202A, a novel GDF15×IL-6 bispecific antibody for the treatment of cachexia (AACR 2025) - "GFS202A was well tolerated in cynomolgus monkey toxicity study, with a weekly dose regimen (qw ×5) the NOAEL was 300 mg/kg. Taking together, these preclinical findings show the potential of GFS202A as an innovative treatment for cachexia, with a projected clinical trial initiation in the first half of 2025."

Fibrosarcoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • GDF15 • IL6 • TGFB1

GenFleet Therapeutics Receives Clinical Trial Approval from China’s NMPA for GFS202A, a Bispecific Antibody Targeting GDF15 and IL-6, in a Phase I Study Treating Cancer Cachexia Patients (openPR) - "GenFleet Therapeutics...announced China's National Medical Products Administration has approved the clinical trial application for GFS202A in an open-label, multi-center phase I study treating cancer patients with precachexia and cachexia...The trial will take place at multiple sites including the prestigious Sun Yat-sen University Cancer Center in Guangdong, China. The phase I study aims to evaluate the safety/tolerability of GFS202A among trial participants, and to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Additionally, the study will assess GFS202A's pharmacokinetic profile, and its impact on improving body weight and appetite...Overseas clinical studies of GDF15 antibodies have achieved proof of concept, validating the improvement of cachexia symptoms through GDF15 inhibition. Furthermore, animal experiments and clinical reports both suggest systemic inhibition of IL-6/IL-6R improves weight loss and reduces inflammatory responses."

New P1 trial • Preclinical • Cachexia • Oncology