JAB-3068 / Jacobio Pharma - LARVOL DELTA

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed

Metastases • Trial completion • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China (clinicaltrials.gov) - P1/2 | N=126 | Completed | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed

Metastases • Trial completion • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

JAB-3068 Activity in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed | Phase classification: P1b/2a ➔ P1/2 | N=118 ➔ 12 | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Feb 2022 ➔ Dec 2023

Combination therapy • Enrollment change • Metastases • Phase classification • Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

After being "returned" by AbbVie, Jacobs terminated the development of a SHP2-targeted drug [Google translation] (Sina Corp) - "...CASI Pharmaceuticals mentioned that the clinical development of the SHP2 allosteric inhibitor JAB-3068 has been terminated....In February of this year, JAB-3312 and the KRAS G12C inhibitor JAB-21822 were approved for Phase III clinical trials in China, becoming the world's first SHP2 inhibitor to enter Phase III registration clinical studies. Relevant clinical data are expected to be announced in the second half of this year."

Discontinued • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Jacobio Pharmaceuticals Co., Ltd. | Trial completion date: Sep 2021 ➔ Sep 2022 | Trial primary completion date: Jul 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

JAB-3068 Activity in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2a; N=118; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Mar 2021 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Jacobio's 2 SHP2 inhibitors nodded for combo studies in China and US (GBI Health) - "China-based Jacobio Pharmaceuticals Group Co., Ltd...announced receiving clinical trial approvals from both the National Medical Products Administration and the US FDA for its SHP2 inhibitors in combination with other drugs. Specifically, Jacobio can now initiate a clinical study for JAB-3068 combined with programmed death ligand-1 (PD-L1) inhibitor in advanced solid tumors in China, and for JAB-3312 in combination with a PD-L1 inhibitor or MEK inhibitor in solid tumors in the US."

IND • Non-US regulatory • Oncology • Solid Tumor

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; N=30 ➔ 45

Clinical • Enrollment change • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China (clinicaltrials.gov) - P1/2; N=120; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Trial completion date: Sep 2020 ➔ Sep 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Jacobio Pharmaceuticals Co., Ltd.; Trial completion date: Apr 2020 ➔ Jan 2021; Trial primary completion date: Nov 2019 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer