^
    3ms
    Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov)
    P2/3, N=374, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Nov 2024 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • SPH4336
    4ms
    Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov)
    P2, N=14, Terminated, Shanghai Pharma Biotherapeutics USA Inc. | N=33 --> 14 | Trial completion date: Mar 2025 --> Oct 2024 | Recruiting --> Terminated | Trial primary completion date: Mar 2025 --> Oct 2024; Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    SPH4336
    7ms
    Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov)
    P2/3, N=374, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Aug 2024 --> Nov 2024
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    letrozole • SPH4336
    10ms
    Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=29, Completed, Shanghai Pharmaceuticals Holding Co., Ltd | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Oct 2023 | Trial primary completion date: Jun 2024 --> Oct 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    SPH4336
    12ms
    Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=29, Active, not recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    SPH4336
    over1year
    Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2/3, N=254, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • SPH4336
    over1year
    Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov)
    P2, N=52, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Sep 2023
    Enrollment open • Trial initiation date • Combination therapy
    |
    fulvestrant • exemestane • SPH4336
    over1year
    A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=63, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
    New P1/2 trial • Combination therapy • Metastases
    |
    Kaitanni (cadonilimab) • SPH4336
    over1year
    Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov)
    P2, N=33, Recruiting, Shanghai Pharma Biotherapeutics USA Inc. | Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Mar 2025 | Initiation date: Dec 2022 --> Jul 2023 | Trial primary completion date: Dec 2025 --> Mar 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    SPH4336
    almost2years
    Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov)
    P2/3, N=374, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • SPH4336
    almost2years
    Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=29, Active, not recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
    New P1/2 trial • Metastases
    |
    SPH4336
    almost2years
    Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
    New P2 trial • Combination therapy
    |
    fulvestrant • exemestane • SPH4336
    almost2years
    Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2/3, N=254, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
    New P2/3 trial • Combination therapy • Metastases
    |
    fulvestrant • SPH4336
    2years
    Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov)
    P2/3, N=374, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
    New P2/3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • SPH4336