^
    12ms
    A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=200, Completed, InventisBio Co., Ltd | Active, not recruiting --> Completed | Trial primary completion date: Oct 2021 --> Oct 2023
    Trial completion • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • taragarestrant (D-0502)
    1year
    A Phase Ⅰb Study of D-0502 as Monotherapy for Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer: Results from the Dose-Expansion Stage (SABCS 2023)
    The phase Ⅰ open-label study (NCT03471663) evaluated the safety, tolerability, pharmacokinetics (PK) and efficacy of D-0502 as monotherapy and in combination with palbociclib in female patients with ER+ and HER2- breast cancer. D-0502 monotherapy showed promising antitumor activity and tolerable toxicity in female patients with ER+ and HER2- locally advanced or metastatic BC. Currently this treatment is being evaluated in a phase Ⅲ study for patients with ER+ and HER2- locally advanced or metastatic BC in China.
    Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    Ibrance (palbociclib) • taragarestrant (D-0502)
    over2years
    A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, InventisBio Co., Ltd | Recruiting --> Active, not recruiting | N=57 --> 200 | Trial completion date: Dec 2022 --> Jul 2023
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • taragarestrant (D-0502)
    over3years
    A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=57, Recruiting, InventisBio Inc. | Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Dec 2021
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • taragarestrant (D-0502)
    4years
    [VIRTUAL] A phase 1 study of D-0502, an orally bioavailable SERD, for advanced or metastatic HR-positive and HER2-negative breast cancer (SABCS 2020)
    Fulvestrant is currently the only approved agent in its class and is limited by poor oral bioavailability necessitating monthly intramuscular injections...In Stage 1, D-0502 was evaluated with palbociclib at a dose below the MTD first before escalating to the MTD... A first-in-human phase 1 study of D-0502 has been initiated in women with advanced or metastatic HR-positive and HER2-negative breast cancer. D-0502 has been well tolerated and achieved significant exposure and preliminary clinical activity in patients. Further results will be presented at the meeting.
    P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HR positive • HER-2 negative • ER mutation • ER Y537S • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • taragarestrant (D-0502)