KN052 / Alphamab - LARVOL DELTA

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Phase classification: P1a/1b ➔ P1 | N=45 ➔ 15 | Trial completion date: May 2024 ➔ Nov 2023 | Recruiting ➔ Terminated; Based on the differentiated R&D strategy, the sponsor applies for the termination of the project.

Enrollment change • Metastases • Phase classification • Trial completion date • Trial termination • Oncology • Solid Tumor

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=45 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Feb 2023 ➔ Dec 2023

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

Late-Breaking Research - Alphamab Oncology Presents Preclinical Results of KN052 at AACR 2023 (PRNewswire) - "Alphamab Oncology...announced that the preclinical result of KN052...were presented as a poster at the Late-Breaking Research session of the AACR Annual Meeting 2023 (AACR 2023)....KN052 displayed high affinity binding to human PD-L1 and OX40 with KD of 2.38E-09M and 1.19E-08M. It can simultaneously bind PD-L1 and OX40, effectively block PD-L1 and PD-1/CD80 pathway and activate OX40 pathway. Additionally, there is synergy between blocking effect and activation effect. The single dose pharmacokinetics study indicated that KN052 has general linear dynamic characteristics, and pharmacokinetics parameters show no significant differences between males and females in the range 3-30 mg/kg. In MC38 and MCA205 animal models, tumor inhibition rate of KN052 at 3 mg/kg and 15 mg/kg was respectively, and has long term antitumor efficacy. The HNSTD of KN052 was determined at 30mg/kg in cynomolgus monkeys, KN052 showed good safety profile at any dose levels."

Preclinical • Oncology

KN-052, a novel PDL1/OX40 bispecific antibody, exhibits potent antitumor efficacy (AACR 2023) - "The HNSTD (highest non-severely toxic dose) of KN052 was determined as 30mg/kg in cynomolgus monkeys. These preclinical data demonstrated acceptable PK and safety profile of KN052 and indicated its potential in a variety of tumors."

Clinical • Late-breaking abstract • Oncology • CD80

Alphamab Oncology to Present the Preclinical Results of PD-L1/OX40 Bispecific Antibody KN052 at AACR 2023 (PRNewswire-Asia) - "Alphamab Oncology ...announced that the preclinical result of KN052 (PD-L1/OX40 bispecific antibody) is accepted as Late-Breaking Research in 114th Annual Meeting of the American Association for Cancer Research (AACR 2023). The results will be presented as poster(Abstract: LB021)....In preclinical studies, KN052 showed significantly stronger activity than either single antibody or in combination. These preclinical data demonstrated acceptable PK and safety profile. KN052 is currently in phase I investigation and the initial clinical data read out is expected in Q3 2023."

Late-breaking abstract • P1 data • Preclinical • Oncology • Solid Tumor

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=45 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Alphamab Oncology Announced First Patient Dosed in Phase I Trial of PD-L1/OX40 Bispecific Antibody KN052 (PRNewswire-Asia) - "Alphamab Oncology...announced that the first patient was dosed in a Phase I clinical study (KN052-CHN-001) of KN052, its proprietary PD-L1/OX40 bispecific antibody, in patients with advanced solid tumors in China....KN052-CHN-001 is a Phase I clinical study in Chinese patients with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN052, and to determine the recommended dose for further development."

Trial status • Oncology • Solid Tumor

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=45 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P1 trial • Oncology • Solid Tumor

Alphamab Oncology Announced IND Approval of PD-L1/OX40 Bispecific Antibody KN052 (PRNewswire-Asia) - "Alphamab Oncology...announced, that the company received the IND approval from the National Medical Products Administration (NMPA) for the company's innovative bispecific antibody KN052 (PD-L1/OX40 bispecific antibody) to initiate clinical trials for the treatment of advanced solid tumors....Based on this IND approval, Alphamab Oncology will conduct a phase Ia/Ib clinical study of KN052 in advanced solid tumors to evaluate its safety, tolerability, PK/PD and efficacy. The study also includes expansion cohorts for appropriate tumor types at respective dose levels."

New P1 trial • Oncology • Solid Tumor