GFS202A / GenFleet Therap - LARVOL DELTA

A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Genfleet Therapeutics (Shanghai) Inc.

Monotherapy • New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • KRAS

GenFleet Therapeutics…is pleased to announce the initiation of a three-arm, parallel-controlled phase II study evaluating two novel combination regimens versus monotherapy of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, among pretreated KRAS G12D-mutant patients with locally advanced unresectable or metastatic pancreatic cancer (HKEXnews) - "The multicenter, open-label, randomized controlled study will be conducted across tens of clinical sites in the Chinese mainland; with Ruijin Hospital Affiliated to Shanghai Jiao Tong University's School of Medicine as the leading site. The two combination therapies include GFH375 plus GFS202A, the world’s first cachexia-targeted bispecific antibody (GDF15/IL-6 bispecific antibody), and GFH375 plus GFH276, a Pan RAS (ON) inhibitor."

New P2 trial • Pancreatic Cancer

A first-in-human (FiH) phase I study of GFS202A, a GDF15/IL-6 bispecific antibody, in advanced cancer patients (pts) with pre-cachexia or cachexia. (ASCO 2026) - P1 | "GFS202A demonstrated favorable safety and encouraging efficacy with systemic inflammation alleviated and weight gain. The data support that dual-targeting GDF15 and IL-6 is a feasible way to mitigate cancer cachexia clinically. Future studies are warranted."

Bispecific • Clinical • First-in-human • Metastases • P1 data • Anorexia • Cachexia • Hypertension • Oncology • GDF15 • IL6 • TGFB1

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."

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

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

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