Hemay181 / Tianjin Hemay Pharma - LARVOL DELTA

A phase Ib clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary anti-tumor efficacy of Hemay181 in patients with advanced solid tumors. (ASCO 2025) - P1 | "In animal Xenograft models, a tumor-to-plasma ratio of 75 fold for Hemay181, 12x Govitecan, 0.3 for Irinotecan showing tumor concentration. Hemay181 in the dose range of 36mg/m2 to 150mg/m2 shows potential therapeutic benefits, with tumor shrinkage demonstrated in advanced breast, lung, and pancreatic cancers. The benefit-risk ratio is favorable, justifying further dose optimization and expansion."

Clinical • Metastases • P1 data • PK/PD data • Anemia • Breast Cancer • Colon Cancer • Colorectal Cancer • Endocrine Disorders • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor

Hemay181: A novel SDC (sugar linked drug conjugate) for solid tumors targeting tumor microenvironment. (ASCO 2024) - "Hemay181 significantly reduced tumour volume compared to irinotecan, which only slowed the tumour growth rates. In summary, the novel broad-spectrum anti-tumour drug Hemay181 has the characteristics of high water solubility, tumour-targeting ability, low toxicity and side effects on normal tissues. It is under evaluation in ongoing clinical studies."

Biomarker • Tumor microenvironment • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • TOP1

A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

Metastases • New P1 trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor