^
    1m
    The SHERPA trial: A phase I study combining SHP2 inhibitor RMC-4630 and ERK inhibitor LY3214996 in patients with KRAS-mutant pancreatic, non-small cell lung and colorectal cancer. (PubMed, Eur J Cancer)
    Sufficient exposure to RMC-4630 and LY3214996 was not reached due to the toxicity profile of the combination. Tumor response was not demonstrated at the explored dose levels. Therefore, the dose escalation was discontinued, and the RP2D was not determined.
    P1 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    vociprotafib (RMC-4630) • temuterkib (LY3214996)
    8ms
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=610, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=1200 --> 610 | Trial primary completion date: Jun 2026 --> Dec 2026
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    1year
    RMC-4630-03: Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies (clinicaltrials.gov)
    P2, N=47, Completed, Revolution Medicines, Inc. | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Sep 2023 --> Jul 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Lumakras (sotorasib) • vociprotafib (RMC-4630)
    over1year
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=1200, Recruiting, Amgen | Trial completion date: Mar 2028 --> Dec 2027
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    over1year
    SHERPA: Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers (clinicaltrials.gov)
    P1, N=24, Terminated, The Netherlands Cancer Institute | N=55 --> 24 | Recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Jul 2024; Due to a lack of safety and efficacy.
    Enrollment change • Trial termination • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    vociprotafib (RMC-4630) • temuterkib (LY3214996)
    over1year
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=1200, Recruiting, Amgen | Trial completion date: Jun 2029 --> Mar 2028 | Trial primary completion date: Jan 2027 --> Apr 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    over1year
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=1200, Recruiting, Amgen | Trial completion date: Mar 2028 --> Jun 2029 | Trial primary completion date: Sep 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    almost2years
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=1200, Recruiting, Amgen | Trial primary completion date: Dec 2026 --> Sep 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    2years
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1, N=1200, Recruiting, Amgen | Phase classification: P1/2 --> P1
    Phase classification • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    2years
    Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=65, Terminated, Sanofi | Active, not recruiting --> Terminated; Sponsor's decision not related to any safety concern
    Trial termination • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NF1 (Neurofibromin 1)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • NF1 mutation • KRAS G12 • BRAF amplification
    |
    Keytruda (pembrolizumab) • Krazati (adagrasib) • vociprotafib (RMC-4630)
    2years
    CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov)
    P1/2, N=1126, Recruiting, Amgen | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Ibrance (palbociclib) • carboplatin • paclitaxel • docetaxel • everolimus • Vectibix (panitumumab) • Lumakras (sotorasib) • pemetrexed • oxaliplatin • irinotecan • batoprotafib (TNO155) • vociprotafib (RMC-4630) • BI 1701963 • zeluvalimab (AMG 404)
    over2years
    Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=65, Active, not recruiting, Sanofi | Trial completion date: Jul 2024 --> Mar 2024 | Trial primary completion date: Jul 2024 --> Mar 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NF1 (Neurofibromin 1)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • NF1 mutation • KRAS G12 • BRAF amplification
    |
    Keytruda (pembrolizumab) • Krazati (adagrasib) • vociprotafib (RMC-4630)