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
Not provided
Not provided
To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Exploration | Experimental | Dose escalation of JAB-21822 to determine maximum tolerated dose. |
|
| Phase IIa Dose Expansion | Experimental | Patients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy. |
|
| Phase IIb | Experimental | Patients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 | Drug | JAB-21822 will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) in the dose escalation phase | Number of participants with dose limiting toxicities | first 21 days |
| 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 |
| Overall response rate (ORR) by IRC (independent review committee) | ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1 | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) by investigator | ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1 | up to 3 years |
| Duration of response ( DOR ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42384131 | Derived | Jiang L, Luo Y, Liang H, Feng X, Huang Y, Li Y, Wang Z, Xu T, Zou H, Li Z, Shen L, Chen Y, Wang W, Li J. The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Hum Cell. 2026 Jul 1;39(7):95. doi: 10.1007/s13577-026-01405-0. | |
| 41344351 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JAB-21822 | Drug | JAB-21822 will be administered orally |
|
|
| JAB-21822 | Drug | JAB-21822 will be administered orally |
|
|
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.
| up to 3 years |
| Disease Control Rate ( DCR ) | DCR is defined as percentage of participants with complete response (CR), partial response (PR), and stable disease(SD) per RECIST v1.1 | up to 3 years |
| 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 per RECIST v1.1, which occurs first | up to 3 years |
| Time to response (TTR) | Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria | up to 3 years |
| Peak Plasma Concentration (Cmax) | Cmax of JAB-21822 will be measured by using plasma PK samples | up to 3 years |
| Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1. |
| 41037823 | Derived | Li J, Deng T, Gu Y, Calles Blanco A, Li Z, Bai C, Wu L, Huang J, Li X, Yao Y, Song Z, Li Y, Liu L, Xing L, Wu W, Martinez-Perez J, Hubert A, Zugazagoitia J, Zhang J, Wang Y, Zhao Y, Wen G, Xia G, Zhong D, Chen X, Jiang K, Wang-Gillam A, Ding Y, Liu S, Rao Z, Liu X, Shen L. Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. Cancer Commun (Lond). 2025 Nov;45(11):1500-1512. doi: 10.1002/cac2.70056. Epub 2025 Oct 2. |
| 39762419 | Derived | Shi Y, Fang J, Xing L, Yao Y, Zhang J, Liu L, Wang Y, Hu C, Xiong J, Liu Z, Yang R, Wang Z, Zhao E, Wang M, Zhao Y, Tang K, Li Z, Song Z, Li Y, Zhuang W, Jin B, Cheng Y, Hu Y, Gu Y, Wu L, Ma R, Yu Q, Yu Y, Zhao J, Zhao H, Lv D, Shang Y, Xing P, Zhou J, Li X, Liu Z, Dai Z, Xia G, Chen X, Ba Y, Bai C, Li Q, An G, Hu W, Wang Y, Wang-Gillam A, Ding Y, Li Q, Rao Z. Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial. Nat Med. 2025 Mar;31(3):894-900. doi: 10.1038/s41591-024-03401-z. Epub 2025 Jan 6. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |