KH815 / Chengdu Kanghong Pharma - LARVOL DELTA

Translational study and first-in-human (FIH) study design of KH815, a novel dual-payload TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1 | "Especially, in a Trodelvy-resistant Triple-Negative Breast Cancer (TNBC) PDX model, KH815 demonstrated significantly superior anti-tumor activity compared to Sacituzumab Govitecan and Datopotamab Deruxtecan. 30 to 60 participants are planned for each dose levels in phase Ib. One patient enrolled as of May 5th, 2025."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KH815, a novel dual-payload TROP2-directed antibody-drug conjugate, shows potent antitumor efficacy in pre-clinical tumor model (AACR 2025) - "Several antibody-drug conjugates (ADCs) targeting TROP2, such as sacituzumab govitecan and datopotamab deruxtecan, have shown promising anti-tumor activity in multiple solid tumors, particularly in breast cancer. The non-GLP toxicity study in cynomolgus monkeys provided evidence of the favorable safety profile of KH815, the highest non-severely toxic dose (HNSTD) is 40 mg/kg/dose.In summary, KH815, an ADC with dual toxins and unique mechanisms of action, displayed superior anti-tumor effects, the ability to overcome drug resistance, and an acceptable safety profile in preclinical studies. These findings support the potential of KH815 as a promising advanced therapeutic candidate for tumors."

Preclinical • Breast Cancer • Oncology • Solid Tumor

KH815, a novel dual-payload TROP2-directed antibody-drug conjugate, shows potent antitumor efficacy in pre-clinical tumor model [WITHDRAWN] (AACR 2025) - "Several antibody-drug conjugates (ADCs) targeting TROP2, such as sacituzumab govitecan and datopotamab deruxtecan, have shown promising anti-tumor activity in multiple solid tumors, particularly in breast cancer. The non-GLP toxicity study in cynomolgus monkeys provided evidence of the favorable safety profile of KH815, the highest non-severely toxic dose (HNSTD) is 40 mg/kg/dose.In summary, KH815, an ADC with dual toxins and unique mechanisms of action, displayed superior anti-tumor effects, the ability to overcome drug resistance, and an acceptable safety profile in preclinical studies. These findings support the potential of KH815 as a promising advanced therapeutic candidate for tumors."

Preclinical • Breast Cancer • Oncology • Solid Tumor

First-In-Human Study in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Chengdu Kanghong Biotech Co., Ltd.

New P1 trial • Oncology • Solid Tumor