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AVZO-021
i
Other names: AVZO-021, ARTS-021, ARTS 021, AVZO 021, ARTS021, AVZO021
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Company:
Allorion Therap, Avenzo Therap
Drug class:
CDK2 inhibitor
Related drugs:
6ms
ARTS-021-1001: Study of AVZO-021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=430, Recruiting, Avenzo Therapeutics, Inc. | N=192 --> 430 | Trial completion date: Apr 2026 --> Jan 2030 | Trial primary completion date: Oct 2025 --> Jan 2028
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1)
|
Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • AVZO-021
1year
Study of ARTS-021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=192, Recruiting, Allorion Therapeutics Inc | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1)
|
HER-2 negative • CCNE1 amplification
|
Ibrance (palbociclib) • carboplatin • fulvestrant • letrozole • AVZO-021
over1year
ARTS-021-1001: Phase I/II study of ARTS-021, a potent, oral administrated, selective CDK2 inhibitor, in advanced or metastatic solid tumors (ESMO 2023)
Trial design This is a first in human, open label, multicenter phase1/2 dose escalation and dose expansion study to evaluate the safety, tolerability, PK, PD, and anti-tumor activity of ARTS-021 1) as a single agent in advanced or metastatic CCNE-1 amplifed solid tumors; 2) in combination with Carboplatin to treat refractory/resistant CCNE-1 amplified ovarian cancer that has failed standard therapies; 3) in combination with endocrine therapy (fulvestrant/letrozole) and CDK4/6 inhibitor(palbociclib/ribociclib/abemaciclib) to treat HR+ HER2- breast cancer patients have failed standard therapies. The secondary endpoint of phase 2 study will be safety/tolerability. Archival tumor and paired fresh tumor biopsy will be collected throughout the study for exploratory pharmacodynamics (PD) and biomarker evaluation.
P1/2 data • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1) • CDK1 (Cyclin-dependent kinase 1)
|
HER-2 negative • CCNE1 amplification
|
Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • AVZO-021
over1year
Study of ARTS-021 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=192, Not yet recruiting, Allorion Therapeutics Inc
New P1/2 trial • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CCNE1 (Cyclin E1)
|
HER-2 negative • CCNE1 amplification
|
Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • AVZO-021
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