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DRUG:

culmerciclib (TQB3616)

i
Other names: TQB3616, TQB-3616, TQB 3616
Company:
Sino Biopharm
Drug class:
CDK4 inhibitor, CDK6 inhibitor, CDK2 inhibitor
17d
Drug-Drug Interaction (DDI) Study for TQB3616 (clinicaltrials.gov)
P1, N=40, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
New P1 trial
|
culmerciclib (TQB3616) • itraconazole • rifampicin
2ms
TQB3616-III-01: TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (clinicaltrials.gov)
P3, N=287, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2025
Enrollment closed • Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
|
fulvestrant • culmerciclib (TQB3616)
8ms
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=154, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=89 --> 154 | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Mar 2025 --> Dec 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
gemcitabine • paclitaxel • capecitabine • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • culmerciclib (TQB3616) • TQB2930
11ms
Enrollment closed • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • PTEN mutation + HR positive
|
fulvestrant • culmerciclib (TQB3616)
11ms
The Potent Novel CDK4/6 Inhibitor TQB3616 in Hormone Receptor Positive Breast Cancer: Preclinical Characterization with in vitro and Human Tumor Xenograft Models. (PubMed, Breast Cancer (Dove Med Press))
Oral administration of TQB3616 showed more potent antitumor activity than abemaciclib in an in vitro breast cancer xenograft model, causing significant tumor regression associated with sustained target inhibition in tumor tissue and manageable in vivo toxicity. The results of this study indicate that TQB3616 is a novel CDK4/6 inhibitor, and its highly effective antitumor activity against breast cancer is expected to yield promising therapeutic effects in clinical studies.
Preclinical • Journal
|
ER (Estrogen receptor)
|
HER-2 positive • ER positive • HR positive • HER-2 negative • ER positive + HER-2 negative
|
Verzenio (abemaciclib) • culmerciclib (TQB3616)
12ms
Mass Balance Study of TQB3616 (clinicaltrials.gov)
P1, N=8, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
New P1 trial
|
culmerciclib (TQB3616)
over1year
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • HR positive + HER-2 negative
|
tamoxifen • letrozole • anastrozole • culmerciclib (TQB3616)
over1year
New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • HR positive + HER-2 negative
|
tamoxifen • letrozole • anastrozole • culmerciclib (TQB3616)
over2years
New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative • ER positive + HER-2 negative
|
fulvestrant • culmerciclib (TQB3616)
over2years
New P3 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
fulvestrant • culmerciclib (TQB3616)
almost3years
New P1/2 trial
|
PD-L1 (Programmed death ligand 1)
|
benmelstobart (APL-502) • culmerciclib (TQB3616)
over3years
Clinical • New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • HR positive + HER-2 negative
|
fulvestrant • culmerciclib (TQB3616)
over3years
Clinical • New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • HR positive + HER-2 negative
|
fulvestrant • culmerciclib (TQB3616)