^
    7ms
    A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China (clinicaltrials.gov)
    P1, N=8, Not yet recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P1 trial
    |
    SY-5007
    8ms
    A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects (clinicaltrials.gov)
    P1, N=28, Not yet recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P1 trial
    |
    SY-5007 • itraconazole • rifampicin
    8ms
    A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects (clinicaltrials.gov)
    P1, N=28, Not yet recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P1 trial
    |
    SY-5007
    1year
    Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC (clinicaltrials.gov)
    P3, N=120, Recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P3 trial • Metastases
    |
    RET (Ret Proto-Oncogene)
    |
    RET fusion • RET positive
    |
    SY-5007
    over1year
    A first-in-human phase I, dose-escalation and dose-expansion study of SY-5007, a highly potent and selective RET inhibitor, in Chinese patients with advanced RET positive solid tumors. (ASCO 2023)
    Recently, selective RET TKIs, selpercatinib and pralsetinib, were approved for RET positive solid tumors by FDA. SY-5007 was well tolerated in patients. Preliminary antitumor activity was also observed in patients with advanced RET-fusion positive NSCLS and RET mutant MTC. The pivotal Phase II clinical study of SY-5007 in NSCLC patients is ongoing.
    Clinical • P1 data • Metastases
    |
    RET (Ret Proto-Oncogene)
    |
    RET fusion • RET mutation • RET positive
    |
    Retevmo (selpercatinib) • Gavreto (pralsetinib) • SY-5007
    over1year
    Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=184, Recruiting, Shouyao Holdings (Beijing) Co. LTD | Trial primary completion date: Mar 2023 --> Jan 2025
    Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • RET (Ret Proto-Oncogene)
    |
    RET fusion • RET mutation • RET positive
    |
    SY-5007
    over1year
    Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Shouyao Holdings (Beijing) Co. LTD | Phase classification: P1 --> P1/2 | N=80 --> 200 | Trial completion date: Jun 2023 --> Feb 2025
    Phase classification • Enrollment change • Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • RET (Ret Proto-Oncogene)
    |
    RET fusion • RET mutation • RET positive
    |
    SY-5007
    over2years
    A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SY-5007 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=80, Recruiting, Shouyao Holdings (Beijing) Co. LTD | Trial primary completion date: Mar 2022 --> Mar 2023
    Trial primary completion date
    |
    RET (Ret Proto-Oncogene)
    |
    RET fusion • RET mutation
    |
    SY-5007
    over2years
    A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SY-5007 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=80, Recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P1 trial
    |
    RET (Ret Proto-Oncogene)
    |
    RET fusion • RET mutation
    |
    SY-5007