^
    12d
    NUMER: Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. (clinicaltrials.gov)
    P2, N=120, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Mekinist (trametinib) • Xalkori (crizotinib) • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • Irene (pyrotinib) • Gavreto (pralsetinib) • Ensacove (ensartinib) • Orpathys (savolitinib) • glecirasib (JAB-21822) • sunvozertinib (DZD9008)
    4ms
    JAB-21822 3002: JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation (clinicaltrials.gov)
    P3, N=392, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    carboplatin • Tevimbra (tislelizumab-jsgr) • pemetrexed • glecirasib (JAB-21822) • JAB-3312
    4ms
    NUMER: Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    Mekinist (trametinib) • Xalkori (crizotinib) • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • Irene (pyrotinib) • Gavreto (pralsetinib) • Ensacove (ensartinib) • Orpathys (savolitinib) • glecirasib (JAB-21822) • sunvozertinib (DZD9008)
    4ms
    JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=48, Active, not recruiting, Jacobio Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    6ms
    A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China (clinicaltrials.gov)
    P1/2, N=311, Active, not recruiting, Jacobio Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | N=144 --> 311
    Enrollment closed • Enrollment change • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    glecirasib (JAB-21822)
    6ms
    A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects (clinicaltrials.gov)
    P1, N=66, Completed, Jacobio Pharmaceuticals Co., Ltd. | Recruiting --> Completed | Trial completion date: Jul 2024 --> Feb 2024 | Trial primary completion date: Jun 2024 --> Feb 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    glecirasib (JAB-21822) • itraconazole • midazolam hydrochloride • omeprazole • rifampicin
    7ms
    JAB-21822 3002: JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation (clinicaltrials.gov)
    P3, N=392, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P3 trial • Metastases
    |
    carboplatin • Tevimbra (tislelizumab-jsgr) • pemetrexed • glecirasib (JAB-21822) • JAB-3312
    9ms
    A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer (clinicaltrials.gov)
    P2, N=69, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability)
    |
    KRAS mutation • MSI-H/dMMR • KRAS G12C • KRAS G12
    |
    glecirasib (JAB-21822)
    11ms
    Mass Balance Study of [14C]JAB-21822 (clinicaltrials.gov)
    P1, N=6, Completed, Jacobio Pharmaceuticals Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    glecirasib (JAB-21822)
    12ms
    A Food Effect Study of JAB-21822 in Healthy Subjects (clinicaltrials.gov)
    P1, N=18, Completed, Jacobio Pharmaceuticals Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Jun 2023
    Trial completion • Trial completion date
    |
    glecirasib (JAB-21822)
    1year
    A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects (clinicaltrials.gov)
    P1, N=66, Recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P1 trial
    |
    glecirasib (JAB-21822) • itraconazole • midazolam hydrochloride • omeprazole • rifampicin
    1year
    Preliminary activity and safety results of KRAS G12C inhibitor glecirasib (JAB-21822) in patients with pancreatic cancer and other solid tumors. (ASCO-GI 2024)
    Glecirasib monotherapy is well tolerated and has a manageable safety profile and exhibits promising anti-tumor activity in pts with KRAS G12C mutated PDAC and other solid tumors. Further clinical development of glecirasib in above mentioned population is ongoing (NCT06008288). Clinical trial information: NCT05009329 and NCT05002270.
    Clinical
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    glecirasib (JAB-21822)
    over1year
    JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Trial primary completion date: Jul 2023 --> Jan 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    over1year
    A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer (clinicaltrials.gov)
    P2, N=69, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P2 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • MSI-H/dMMR • KRAS G12C • KRAS G12
    |
    glecirasib (JAB-21822)
    over1year
    Glecirasib (KRAS G12C inhibitor) in combination with JAB-3312 (SHP2 inhibitor) in patients with KRAS p.G12C mutated solid tumors (ESMO 2023)
    Conclusions Glecirasib plus JAB-3312 was well tolerated with promising efficacy in KRAS p.G12C NSCLC. Currently, dose expansion is underway to further evaluate efficacy and safety.
    Clinical • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    glecirasib (JAB-21822) • JAB-3312
    2years
    A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 (clinicaltrials.gov)
    P1/2, N=104, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    KRAS mutation • KRAS G12C • STK11 mutation • KEAP1 mutation • KRAS G12
    |
    glecirasib (JAB-21822)
    over2years
    Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation (clinicaltrials.gov)
    P1/2, N=124, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting | N=72 --> 124
    Enrollment open • Enrollment change • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    glecirasib (JAB-21822) • JAB-3312
    over2years
    A phase I/II study of first-in-human trial of JAB-21822 (KRAS G12C inhibitor) in advanced solid tumors. (ASCO 2022)
    JAB-21822 was well tolerated with impressive preliminary efficacy in patients with heavily treated solid tumors harboring KRAS G12C mutation. The study is enrolling patients in the expansion phase. Multiple JAB-21822-based combination trials are also ongoing.
    P1/2 data
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C
    |
    glecirasib (JAB-21822)
    over2years
    JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=62, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    almost3years
    Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation (clinicaltrials.gov)
    P1/2, N=72, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P1/2 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    glecirasib (JAB-21822) • JAB-3312
    almost3years
    Study to investigate JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation Estudio para evaluar JAB-21822 en monoterapia y en combinación en pacientes adultos con tumores sólidos avanzados portadores de la mutación KRAS G12C (clinicaltrialsregister.eu)
    P1/2, N=136, Ongoing, Jacobio Pharmaceuticals Co., Ltd.
    New P1/2 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability)
    |
    KRAS mutation • MSI-H/dMMR
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    almost3years
    A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 (clinicaltrials.gov)
    P1/2, N=104, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    KRAS mutation • KRAS G12C • STK11 mutation • KEAP1 mutation • KRAS G12
    |
    glecirasib (JAB-21822)
    almost3years
    JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=62, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    New P1/2 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    over3years
    JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Jacobio Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)
    over3years
    FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China (clinicaltrials.gov)
    P1/2, N=144, Recruiting, Jacobio Pharmaceuticals Co., Ltd.
    Clinical • New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    glecirasib (JAB-21822)
    over3years
    JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Jacobio Pharmaceuticals Co., Ltd.
    Clinical • New P1/2 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • glecirasib (JAB-21822)