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    DRUG CLASS:

    KRAS G12D inhibitor

    Related drugs:
    1d
    Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P3, N=320, Not yet recruiting, Genfleet Therapeutics (Shanghai) Inc.
    New P3 trial
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    KRAS (KRAS proto-oncogene GTPase)
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    gemcitabine • paclitaxel • 5-fluorouracil • irinotecan • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur)
    3d
    A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov)
    P1/2, N=126, Recruiting, Genfleet Therapeutics (Shanghai) Inc.
    New P1/2 trial
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    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • gemcitabine • paclitaxel
    3d
    A targeted combination therapy achieves effective pancreatic cancer regression and prevents tumor resistance. (PubMed, Proc Natl Acad Sci U S A)
    Likewise, a combination of selective inhibitors of KRAS (RMC-6236/daraxonrasib), EGFR family (afatinib), and STAT3 (SD36) induced the complete regression of orthotopic PDAC tumors with no evidence of tumor resistance for over 200 d posttreatment...Of importance, this combination therapy was well tolerated. In sum, these results should guide the development of new clinical trials that may benefit PDAC patients.
    Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53)
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    TP53 mutation • KRAS mutation
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    Gilotrif (afatinib) • MRTX1133 • daraxonrasib (RMC-6236)
    8d
    iEXPLORE: iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation (clinicaltrials.gov)
    P1/2, N=28, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1 --> P1/2
    Phase classification
    |
    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12D • KRAS G12
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    Undisclosed MSC-derived Exosomes with KrasG12D siRNA
    9d
    A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants (clinicaltrials.gov)
    P1, N=63, Completed, Incyte Corporation | Recruiting --> Completed
    Trial completion
    |
    itraconazole • rifampicin
    14d
    HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Zhejiang University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
    17d
    HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P3, N=588, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    HRS-4642
    17d
    GFH375X1201: A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Genfleet Therapeutics (Shanghai) Inc. | N=83 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2027 --> Aug 2027
    Enrollment change • Trial withdrawal • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    18d
    HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=20, Recruiting, West China Hospital | N=10 --> 20
    Enrollment change
    |
    TheraCIM (nimotuzumab) • HRS-4642
    28d
    ALAFOSS-01: A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation (clinicaltrials.gov)
    P1/2, N=17, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=430 --> 17 | Trial completion date: Jan 2028 --> Jun 2026 | Trial primary completion date: Jan 2028 --> Oct 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab)
    1m
    INCB161734-101: A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (clinicaltrials.gov)
    P1, N=710, Recruiting, Incyte Corporation | N=466 --> 710
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • Zynyz (retifanlimab-dlwr) • INCA33890
    1m
    Hybrid nanovesicles enhance antitumor efficacy in KRAS-mutant non-small cell lung cancer. (PubMed, J Control Release)
    We evaluated this nanocarrier-based therapeutic strategy for delivering the KRASG12D inhibitor MRTX1133 in KRASG12D-mutant cell lines and animal models...Mechanistically, it reprograms the tumor microenvironment by sustaining MAPK and PI3K pathway inhibition, reducing EGFR phosphorylation, enhancing CD8+ T-cell infiltration, and restoring antitumor immunity through PD-L1 blockade. By exploiting the signaling vulnerabilities of KRAS-driven tumors, our hybrid nanovesicle platform provides a promising therapeutic strategy for overcoming resistance and improving therapeutic response in KRAS-mutant NSCLC.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8)
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    PD-L1 expression • KRAS mutation • KRAS G12D
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    MRTX1133