The aim of this phase 1b study in Chinese patients with ER+/Her2- advanced breast cancer is to evaluate the safety and tolerability of ZN-c5 at dose of 50 mg and 150 mg QD well tolerance established in the previous oversea study in non-Chinese patients.
Hormone receptor-positive, HER2-negative breast cancer is the most common subset of breast cancer. The estrogen receptor (ER) in these patients is a key driver of disease progression, and the primary reason for relapse in these patients is that endocrine therapies are only partially effective, typically causing cell cycle arrest rather than cell death. As a result, secondary resistance to endocrine therapy is a major clinical challenge. ZN-c5 is a novel and potent ZN-c5 is a novel and potent selective estrogen receptor degrader with oral bioavailability and strong activity in estrogen-dependent and tamoxifen-resistant tumor models.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ZN-c5
Fudan University Cancer Hospital
Shanghai, China
Observed Dose Limited Toxicities (DLTs) in safety lead in phase
Safety lead in phase at dose of 50 mg QD: Determine a tolerated dose for ZN-c5 in monotherapy
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence of treatment-emergent adverse events
Investigate the safety and tolerability of dose of 50 mg QD of ZN-c5
Time frame: until 30 days after the last dose of study drug
Incidence of treatment-emergent adverse events
Investigate the safety and tolerability of dose of 150 mg QD of ZN-c5
Time frame: until 30 days after the last dose of study drug
CBR (CR [+ PR] + SD ≥ 24 weeks).
Investigate the preliminary antitumor activity (clinical benefit rate \[CBR\]) for ZN-c5 as a monotherapy using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Time frame: 2 year
bjective Response Rate (ORR)
Assess preliminary antitumor activity of ZN-c5 alone by Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Time frame: 2 year
Duration of Response (DOR)
Assess preliminary antitumor activity of ZN-c5 alone by Duration of Response (DOR) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
Time frame: 2 year
Progression-Free Survival (PFS)
Assess preliminary antitumor activity of ZN-c5 alone by Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) as assessed by investigators.
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Time frame: 2 year