^
    2d
    E7386 in patients with advanced solid tumors: results from the dose-escalation part and an expansion part of a phase I study. (PubMed, ESMO Open)
    In heavily pretreated patients with advanced solid tumors, E7386 demonstrated a manageable safety profile and a dose-dependent PK profile. PRs were noted in patients with small bowel carcinoma or desmoid tumor.
    P1 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    TP53 mutation • KRAS mutation
    |
    E7386
    3ms
    E7386 enhances lenvatinib's antitumor activity in preclinical models and human hepatocellular carcinoma. (PubMed, Clin Cancer Res)
    E7386 sensitized tumors to lenvatinib, thereby enhancing survival in mice compared with either monotherapy. In patients, E7386 combined with lenvatinib promoted tumor shrinkage and, in parallel, activated ATF4 signaling.
    Preclinical • Journal • IO biomarker
    |
    CREBBP (CREB binding protein) • ATF4 (Activating Transcription Factor 4) • TCF4 (Transcription Factor 4)
    |
    Lenvima (lenvatinib) • E7386
    7ms
    E7386-J081-102: A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor (clinicaltrials.gov)
    P1/2, N=301, Recruiting, Eisai Inc. | Trial completion date: Nov 2026 --> Aug 2027 | Trial primary completion date: Nov 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
    |
    paclitaxel • Lenvima (lenvatinib) • doxorubicin hydrochloride • E7386
    11ms
    A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC) (clinicaltrials.gov)
    P1, N=70, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    RNF43 (Ring Finger Protein 43) • APC (APC Regulator Of WNT Signaling Pathway) • AXIN1 (Axin 1) • ZNRF3 (Zinc And Ring Finger 3)
    |
    APC mutation • CTNNB1 mutation • RNF43 mutation
    |
    E7386
    1year
    KEYNOTE-C83: A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors (clinicaltrials.gov)
    P1/2, N=89, Completed, Eisai Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • E7386
    1year
    E7386-J081-102: A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor (clinicaltrials.gov)
    P1/2, N=301, Recruiting, Eisai Inc. | Phase classification: P1 --> P1/2 | N=181 --> 301 | Trial completion date: Mar 2027 --> Nov 2026 | Trial primary completion date: Mar 2027 --> Nov 2026
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
    |
    paclitaxel • Lenvima (lenvatinib) • doxorubicin hydrochloride • E7386
    over1year
    KEYNOTE-C83: A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors (clinicaltrials.gov)
    P1/2, N=89, Active, not recruiting, Eisai Inc. | Trial completion date: Sep 2025 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • E7386
    over1year
    KEYNOTE-C83: A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors (clinicaltrials.gov)
    P1/2, N=89, Active, not recruiting, Eisai Inc. | Recruiting --> Active, not recruiting | N=156 --> 89
    Enrollment closed • Enrollment change • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • E7386
    over1year
    Study of E7386 in Participants With Selected Advanced Neoplasms (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Eisai Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Mar 2026 | Trial primary completion date: May 2024 --> Mar 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    E7386
    over1year
    A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=181, Recruiting, Eisai Inc. | Trial completion date: Oct 2024 --> Mar 2027 | Trial primary completion date: Oct 2024 --> Mar 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
    |
    Lenvima (lenvatinib) • E7386
    almost2years
    A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC) (clinicaltrials.gov)
    P1, N=70, Active, not recruiting, Eisai Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    RNF43 (Ring Finger Protein 43) • APC (APC Regulator Of WNT Signaling Pathway) • AXIN1 (Axin 1) • ZNRF3 (Zinc And Ring Finger 3)
    |
    APC mutation • CTNNB1 mutation • RNF43 mutation
    |
    E7386
    almost2years
    A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=181, Recruiting, Eisai Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
    |
    Lenvima (lenvatinib) • E7386