3HP-2827 / 3H Pharma - LARVOL DELTA

First-in-human phase I/II study of a highly selective FGFR2 inhibitor 3HP-2827 in patients with advanced solid tumors harboring FGFR2 alterations. (ASCO 2026) - P1/2 | "3HP-2827 was found to be safe and tolerable, with encouraging anti-tumor activity observed in pts with FGFR2 alterations. Further clinical efficacy will be explored in the expansion stage and phase II stage. Clinical trial information: NCT06378593."

Clinical • First-in-human • Metastases • P1/2 data • Biliary Cancer • Cholangiocarcinoma • Dental Disorders • Dry Eye Disease • Oncology • Ophthalmology • Solid Tumor • Stomatitis • Xerostomia • FGFR2

Early Data Show Highly Selective FGFR2 Inhibitor 3HP-2827 Active in Advanced CCA; Chinese Academy of Sciences' Zhou Jian Comments on Potential for Patients With FGFR2 Alterations (The Manila Times) - "The clinical data released by 3H Pharmaceuticals at the meeting showed that among patients with FGFR2-mutated solid tumors, 3HP-2827 achieved a best objective response rate (ORR) of 57.1% and a disease control rate (DCR) of 100%. Although the number of enrolled patients remains small at this stage, the cohort already includes multiple clinically relevant FGFR2 mutation sites, including N549K, Y375C, C382R and F276C."

P1/2 data • Cholangiocarcinoma • Solid Tumor

Preclinical development of 3H-10000, a novel vedotin antibody-drug conjugate for treatment of FGFR2b-expressing cancers (AACR 2026) - "More important is that there existed significant synergy in tumor growth inhibition and regression in SNU-16 CDX study, when 3H-10000 was combined with a FGFR2 selective small molecule inhibitor 3HP-2827, which would strongly support clinic trail exploration of the combined therapy strategy of FGFR2b-ADC and 3HP-2827 to overcome drug resistance and perform persistent therapeutic efficacy. The safety study demonstrated that 3H-10000 spared corneal toxicity in mice compared with Bemarituzumab...Overall, 3H-10000, the novel FGFR2b ADC, is a highly potent targeted therapy candidate against cancers.Overall, this study is the first to our knowledge where the combinational treatment of FGFR2b ADC and FGFR2 selective kinase inhibitor demonstrated synergic inhibition of tumor cell growth. These results strongly support advancing 3H-10000 into clinical evaluation in treatment of unnormal FGFR2 expressing solid tumors, and a phase I study has (CTR20254555) is ongoing."

ADC • Late-breaking abstract • Preclinical • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGFR2

3HP-2827-high selective inhibitor of FGFR2, a best-in-class therapy for FGFR2‑driven solid tumors (AACR 2024) - "In the ICC PDX model, 3HP-2827 also induces the regression of pemigatinib-resistant tumors. 3HP-2827 is well tolerated in the toxicology studies, and no hyperphosphatemia or tissue mineralization is observed at 150 mg/kg/kg/day in rats and 120 mg/kg/day in dogs. The data support that 3HP-2827, a potential to be a best-in-class selective FGFR2 inhibitor, will be studying clinically at the beginning of 2024."

Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR1 • FGFR2 • FGFR3

A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd. | Initiation date: Jun 2024 ➔ Jun 2025

Metastases • Trial initiation date • Oncology • Solid Tumor

A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Mar 2028 ➔ Jun 2028

Enrollment open • Metastases • Trial primary completion date • Oncology • Solid Tumor

A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor

A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumours With FGFR2 Alterations (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd.

New P1 trial • Oncology • Solid Tumor