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This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-3068 (SHP2 inhibitor) | Experimental | Daily oral administration of JAB-3068 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-3068 | Drug | JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before (6 hours for PK days) and 2 hours after each dosing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities | Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068. | up to 28-day per cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| pERK | On treatment versus baseline comparison of pharmacodynamic marker pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor biopsy samples by IHC. | Approximately 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacobio Pharmaceuticals | Jacobio Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthONE Clinic Services Oncology-Hematology | Denver | Colorado | 80202 | United States | ||
| Florida Cancer Specialists |
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| Area under the curve |
Area under the plasma concentration time curve of JAB-3068 |
| Approximately 2 years |
| Cmax | Highest observed plasma concentration of JAB-3068 | Approximately 2 years |
| Tmax | Time of highest observed plasma concentration of JAB-3068 | Approximately 2 years |
| T1/2 | Half life of JAB-3068 | Approximately 2 years |
| Objective response rate | ORR is defined as the proportion of participants with complete response or partial response (CR+PR) | Approximately 2 years |
| Duration of response | DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. | Approximately 2 years |
| Sarasota |
| Florida |
| 37203 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009634 | Noonan Syndrome |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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