Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 ,Dose Exploration ,monotherapy | Experimental | Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D |
|
| Phase 2, Dose Expansion, Part1 monotherapy | Experimental | Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC) |
|
| Phase 2 Dose Expansion, Part 2 monotherapy | Experimental | Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB 21822 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) | A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1. It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness. | At the end of Cycle 1 (each cycle is 21 days) |
| Dose Escalation phase: Number of participants with adverse events | Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria | Up to 3 years |
| Dose Expansion phase: Objective response rate (ORR) | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 | Up to 3 years - from baseline to confirmed Progressive Disease per RECIST. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation phase: Objective response rate (ORR) | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 | Up to 3 years - from baseline to RECIST confirmed Progressive Disease |
| Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd | Contact | 021-80423288 | zhenhua.gong@allist.com.cn | |
| Wang Jie Wang Jie M.D. | Contact | 010-87788029 | zlhuxi@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site08 | Not yet recruiting | Beijing | Beijing Municipality | 100010 | China | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST1.1 or death whichever occurs first |
| Up to 3 years |
| Dose Escalation and Dose Expansion phase: Duration of response (DOR) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR) | DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Overall Survival (OS) | Defined as time from first treatment to death by any cause | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Time to response (TTR) | Defined as time from first treatment to first evidence of PR or CR | Up to 3 years |
| Dose Expansion phase: Number of participants with adverse events | Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax) | Cmax of JAB-21822 will be measured by using plasma PK samples | Up to 3 Years |
| Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax) | Tmax of JAB-21822 will be measured by using plasma PK samples | Up to 3 Years |
| Escalation and Dose Expansion phase:Area under the plasma concentration-time curve (AUC) | AUC of JAB-21822 will be measured by using plasma PK samples | Up to 3 Years |
| Research site09 |
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| 100010 |
| China |
| Research site021 | Not yet recruiting | Beijing | Beijing Municipality | 100032 | China |
| Research site02 | Not yet recruiting | Beijing | Beijing Municipality | 100089 | China |
| Research site01 | Recruiting | Beijing | Beijing Municipality | 100101 | China |
|
| Research site013 | Not yet recruiting | Beijing | Beijing Municipality | 101100 | China |
| Research site010 | Not yet recruiting | Chongqing | Chongqing Municipality | 400000 | China |
| Research site05 | Not yet recruiting | Xiamen | Fujian | 361000 | China |
| Research site011 | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
| Research site016 | Not yet recruiting | Nanning | Guangxi | 530000 | China |
| Research site017 | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
| Research site018 | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
| Research site04 | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
| Research site012 | Not yet recruiting | Changsha | Hunan | 410000 | China |
| Research site015 | Not yet recruiting | Changchun | Jilin | 130000 | China |
| Research site06 | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
| Research site07 | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
| Research site014 | Not yet recruiting | Hohhot | Neimenggu | 010000 | China |
| Research site020 | Not yet recruiting | Xi’an | Shanxi | 710000 | China |
| Research site03 | Not yet recruiting | Hubei | Wuhan | 430060 | China |
| Research site019 | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
Not provided
Not provided