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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.
To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-3068+PD1 inhibitor Part1 | Experimental | JAB-3068+JS001 dose escalation |
|
| JAB-3068+PD1 inhibitor Part2 | Experimental | JAB-3068+JS001 dose expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-3068 | Drug | JAB-3068 administrated orally as a tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities | Incidence of dose limiting toxicities (DLTs) . 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 and JS001. | 24 months |
| Objective response rate (ORR) | ORR is defined as the proportion of participants with complete response or partial response (CR+PR). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration (Cmax) | Highest observed plasma concentration of JAB-3068 and JS001 | 24 months |
| Time to achieve Cmax (Tmax) | Time of highest observed plasma concentration of JAB-3068 and JS001 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| Cancer Hospital Chinese Academy of Medical Sciences |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| PD1 inhibitor | Drug | JS001 administrated as an intravenous(IV) infusion. |
|
| 24 months |
| Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration time curve of JAB-3068 and JS001 | 24 months |
| Duration of response ( DCR ) | DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). | 24 months |
| Progression-free survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. | 24 months |
| Duration of response ( DOR ) | 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. | 24 months |
| Overall survival (OS) | OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. | 24 months |
| Number of Participants with Treatment-related Adverse Events(TRAE) | TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug. | 24 months |
| Beijing |
| Beijing Municipality |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |