^
    4ms
    A Study of [14C]IBI351 in Healthy Subjects (clinicaltrials.gov)
    P1, N=6, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Completed
    Trial completion
    |
    fulzerasib (GFH925)
    6ms
    A Study of IBI351 in Healthy Subjects (clinicaltrials.gov)
    P1, N=24, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Completed | Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    fulzerasib (GFH925)
    6ms
    A Study of IBI351 in Healthy Subjects (clinicaltrials.gov)
    P1, N=24, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Completed | Trial completion date: May 2023 --> Oct 2023 | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    fulzerasib (GFH925) • itraconazole
    7ms
    Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: Updated results from a pooled analysis of two phase I studies (ESMO Asia 2023)
    Conclusions The updated results of IBI351 (GFH925) monotherapy showed promising durable efficacy and manageable safety in metastatic CRC harboring KRASG12C mutation. During longer follow-up, these two ongoing studies are expected to provide more robust evidence.
    P1 data • Retrospective data • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    fulzerasib (GFH925)
    7ms
    Efficacy and safety of IBI351 (GFH925), a selective KRASG12C inhibitor, monotherapy in patients (pts) with advanced non-small cell lung cancer (NSCLC): Initial results from a registrational phase II study (ESMO Asia 2023)
    Conclusions IBI351 continues to demonstrate encouraging efficacy with manageable safety. These results support IBI351 monotherapy as a potential new treatment option for advanced KRASG12C mutant NSCLC pts.
    Clinical • P2 data • Late-breaking abstract • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C
    |
    fulzerasib (GFH925)
    9ms
    A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations (clinicaltrials.gov)
    P1/2, N=264, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | N=128 --> 264
    Enrollment change • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    fulzerasib (GFH925)
    11ms
    Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=144, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: May 2023 --> May 2024
    Enrollment open • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    carboplatin • Tyvyt (sintilimab) • pemetrexed • fulzerasib (GFH925)
    12ms
    A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=45, Recruiting, Zhejiang Genfleet Therapeutics Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • fulzerasib (GFH925)
    1year
    Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: Preliminary results from a pooled analysis of two phase I studies. (ASCO 2023)
    IBI351 (GFH925) monotherapy demonstrated promising anti-tumor activity with manageable safety profile in metastatic CRC patients harboring KRASG12C mutation. These two studies are still ongoing and longer follow-up will provide more solid evidence. Updated data will be presented at the meeting.
    P1 data • Retrospective data • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    fulzerasib (GFH925)
    1year
    A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, Zhejiang Genfleet Therapeutics Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • fulzerasib (GFH925)
    over1year
    A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=80, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2022 --> Aug 2023
    Enrollment open • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • fulzerasib (GFH925)
    over1year
    Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=144, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • carboplatin • Tyvyt (sintilimab) • pemetrexed • fulzerasib (GFH925)
    over1year
    A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations (clinicaltrials.gov)
    P1/2, N=128, Recruiting, Zhejiang Genfleet Therapeutics Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    fulzerasib (GFH925)
    over2years
    A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations (clinicaltrials.gov)
    P1/2, N=128, Not yet recruiting, Zhejiang Genfleet Therapeutics Co., Ltd.
    Clinical • New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    fulzerasib (GFH925)