HEC921 / Sunshine Lake Pharma - LARVOL DELTA

HEC-921 Injection as Monotherapy and in Combination With Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Colon Adenocarcinoma • Colon Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • LY6G6D

HEC-921 Injection as Monotherapy and in Combination With Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

Monotherapy • New P1 trial • Colon Adenocarcinoma • Colon Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • LY6G6D

On June 18, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) officially accepted the clinical trial application for Sunshine Lake Pharma’s new bispecific antibody HEC-921 injection. (Minichart) - "HEC-921, developed in-house, is a bispecific antibody targeting LY6G6D and 4-1BB, designed to treat advanced solid tumors, with a primary focus on LY6G6D-positive colorectal cancer...HEC-921 has demonstrated robust anti-tumor activity in multiple animal models, synergistic effects with anti-PD-1 antibodies and chemotherapy, and a favorable safety profile in cynomolgus monkeys...The Phase I clinical trial is expected to commence within 2026, targeting patients with advanced solid tumors, specifically those with LY6G6D-positive colorectal cancer."

New P1 trial • Preclinical • Colorectal Cancer

HEC-922:A CDH17-4-1BB bispecific antibody targeting CDH17 positive tumors shows potent anti-tumor activity (AACR 2026) - "Initial drug feasibility and toxicity studies results of HEC-922 were favorable. Overall result demonstrated that HEC- 922 is a promising candidate for CDH17 positive cancer immunotherapy.HEC-921, another bispecific antibody developed on the same 4-1BB platform with Ly6G6D as the targeted tumor antigen, has completed Dose Range Finding (DRF) study in cynomolgus monkeys, with a no-observed-adverse-effect level (NOAEL) of 100 mg/kg, validating the safety of the 4-1BB platform."

Bispecific • IO biomarker • Colorectal Cancer • Gastric Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • CDH17 • LY6G6D

A novel Ly6G6D/4-1BB bispecific antibody targeting DNA mismatch repair proficient colorectal cancers shows potent antitumor activities (AACR 2025) - "Initial drug feasibility and toxicity studies results of HEC921 were favorable. Overall result demonstrated that HEC921 is a promising candidate for Ly6G6D positive cancer immunotherapy."

Bispecific • IO biomarker • Mismatch repair • pMMR • Colorectal Cancer • Oncology • Solid Tumor • IFNG • IL2 • IL4 • LY6G6D