SMP-656 / Chengdu Kelingyuan Pharma - LARVOL DELTA

SMP-656 for HER2-Positive Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Chengdu SciMount Pharmatech Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Preclinical development of SMP-656: An eribulin-SuperHydraTM linker based ADC (AACR 2025) - "The SuperHydraTM linker enabled SMP-656 to combine superior stability, efficacy, and safety with the ability to overcome DS-8201a resistance. SMP-656 represents the safest and most effective eribulin-based ADC and is currently in Phase I clinical trials, showing promising tolerability and efficacy."

ADC • Preclinical • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I/Ib data of SMP-656: A novel eribulin-based HER2 ADC in solid tumor (ESMO Asia 2025) - "SMP-656 showed promising antitumor activity in ADC-treated population. Phase 2/3 study will be promoted."

P1 data • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • TOP1

Phase I study data of a novel eribulin-based HER2 ADC: Safety and efficacy of SMP-656 in HER2-expressing solid tumor (ESMO 2025) - "It showed potent efficacy in HER2 ADC resistant preclinical models (T-DM1 and T-Dxd). Further development in HER2 ADC-treated breast cancer patients including will be promoted. Legal entity responsible for the study The authors."

Clinical • P1 data • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Xilingyuan Pharmaceutical completed the enrollment of subjects for the first ADC anti-tumor drug SMP-656 [Google translation] (CPHI.cn) - "...Chengdu Kelingyuan Pharmaceutical Technology Co., Ltd...announced its independently developed Class 1 HER2 ADC - new anti-tumor drug SMP- 656, the Phase I clinical study successfully completed the first human administration at Fudan University Cancer Hospital...This is a non-randomized, single-arm, open-label, two-phase, multi-center clinical study designed to evaluate the safety and tolerability of intravenous administration of SMP-656 in patients with HER2-expressing or mutated advanced solid tumors, pharmacokinetic characteristics, immunogenicity and preliminary effectiveness."

Enrollment closed • Oncology • Solid Tumor • HER-2