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DRUG:

RMC-9805

i
Other names: RMC-9805, KRASG12D inhibitor, KRAS G12D inhibitor, RMC9805, RMC 9805
Company:
Revolution Medicines
Drug class:
KRAS G12D inhibitor
4ms
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors (clinicaltrials.gov)
P1, N=444, Recruiting, Revolution Medicines, Inc. | N=290 --> 444 | Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: Aug 2025 --> Apr 2026
Enrollment change • Trial completion date • Trial primary completion date • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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RMC-6236 • RMC-9805
1year
New P1 trial • Metastases
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • KRAS G12D • KRAS G12
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RMC-9805
over1year
RMC-9805, a first-in-class, mutant-selective, covalent and orally bioavailable KRASG12D(ON) inhibitor, promotes cancer-associated neoantigen recognition and synergizes with immunotherapy in preclinical models (AACR 2023)
TCR sequencing of T cells from tumors and blood harvested from treated mice revealed a significant increase in T cell diversity, as well as an increase in the number of shared TCR clones among all KRASG12D(ON) inhibitor-treated samples, suggesting cancer-associated antigen recognition.Overall, in these preclinical experiments, RMC-9805 exhibited direct anti-tumor effects and indirectly transformed the TME through inhibition of cancer cell-intrinsic KRASG12D oncogenic signaling. The increased antigen presentation, recognition, and T cell infiltration induced by inhibition of mutant KRAS may permit a more favorable environment for immune-directed ‘companion’ therapies, such as checkpoint inhibitors, cellular therapies, and/or vaccines.[1] Timar, J. et al, 2020 [2] Hamarsheh, S. et al, 2020 [3] Sumimoto, H. et al, 2016
Preclinical • PD(L)-1 Biomarker • IO biomarker
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • KRAS G12D
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RMC-9805
over1year
RMC-9805, a first-in-class, mutant-selective, covalent and oral KRASG12D(ON) inhibitor that induces apoptosis and drives tumor regression in preclinical models of KRASG12D cancers (AACR 2023)
Furthermore, RMC-9805 combination therapies drove regressions in CRC models relatively less responsive to monotherapy. Supported by these findings, RMC-9805 is currently in IND-enabling development to permit clinical evaluation of single agent and combination strategies in patients with KRASG12D tumors.
Preclinical • PD(L)-1 Biomarker • IO biomarker
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • KRAS G12D • RAS mutation
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RMC-9805