^
    14d
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    1year
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    2years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Boehringer Ingelheim | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over2years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=29, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over2years
    First-in-human, phase Ia/b, dose-escalation/expansion study of KRAS G12C inhibitor BI 1823911, as monotherapy and combined with anticancer therapies, in patients (pts) with advanced or metastatic solid tumours harbouring a KRAS G12C mutation (ESMO 2023)
    Conclusions Preliminary data suggest BI 1823911 monotherapy is generally well tolerated and offers clinical activity. Recruitment is ongoing; updated data will be presented.
    Clinical • P1 data • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    BI 1823911
    over2years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=29, Recruiting, Boehringer Ingelheim | N=72 --> 29 | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Nov 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over3years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=60, Recruiting, Boehringer Ingelheim | Trial completion date: Jan 2024 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over3years
    Trial in progress: Phase 1 study of BI 1823911, an irreversible KRASG12C inhibitor targeting KRAS in its GDP-loaded state, as monotherapy and in combination with the pan-KRAS SOS1 inhibitor BI 1701963 in solid tumors expressing KRASG12C mutation (AACR 2022)
    Inhibition of KRASG12C mediated signaling and the therapeutic impact in non-small cell lung cancer (NSCLC) whose tumors carry this mutation was demonstrated clinically by sotorasib and adagrasib leading to approval of sotorasib in KRASG12C mutant NSCLC...The pan-KRAS SOS1 inhibitor BI 1701963 is the first direct KRAS signaling modifier, which entered phase I clinical trials both as a monotherapy as well as in combination with KRASG12C inhibitors, MEK inhibitors and irinotecan...Primary endpoints include dose-limiting toxicities, treatment-emergent or -related adverse events. Secondary endpoints include pharmacokinetic properties of combination regimens and preliminary efficacy.
    P1 data • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G13 • KRAS expression
    |
    Lumakras (sotorasib) • irinotecan • Krazati (adagrasib) • BI 1823911 • BI 1701963
    almost4years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=60, Recruiting, Boehringer Ingelheim | N=245 --> 60 | Trial completion date: Oct 2024 --> Jan 2024 | Trial primary completion date: Oct 2024 --> Dec 2023
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    4years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=245, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over4years
    A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation (clinicaltrials.gov)
    P1a/1b, N=245, Not yet recruiting, Boehringer Ingelheim
    Clinical • New P1 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    BI 1823911 • BI 1701963 • midazolam hydrochloride
    over4years
    [VIRTUAL] Trial in Process: Phase 1 studies of BI 1701963, a SOS1::KRAS Inhibitor, in combination with MEK inhibitors, irreversible KRASG12C inhibitors or irinotecan. (AACR 2021)
    Here, we present pre-clinical data showing enhanced pathway modulation and synergistic anti-tumor effects following vertical pathway inhibition of BI 1701963 in combination with mitogen-activated protein kinase inhibitors (MEKi; trametinib and BI 3011441) or KRAS G12C inhibitors (MRTX849 and BI 1823911). Primary endpoints include dose-limiting toxicities, treatment-emergent or -related adverse events. Secondary endpoints include pharmacokinetic and pharmacodynamic properties of combination regimens and preliminary efficacy.
    P1 data • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • SOS1 (SOS Ras/Rac Guanine Nucleotide Exchange Factor 1)
    |
    KRAS mutation • KRAS G12D • KRAS G13
    |
    Mekinist (trametinib) • irinotecan • Krazati (adagrasib) • LNP3794 • BI 1823911 • BI 1701963