Clinical trial NCT05628870: A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
Official title: A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of HRS-1358
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).


Eligibility criteria: Inclusion Criteria:

1. Histologically diagnosis of local advanced or metastatic breast cancer
2. Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
3. At least 1 line of endocrine therapy in the metastatic or advanced setting
4. ECOG performance status score: 0-1;
5. Adequate organ functions as defined
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. the investigators judged that it was not suitable to endocrine therapy
2. patients with active brain metastasis (without medical control or with clinical symptoms),
3. History of clinically significant cardiovascular or cerebrovascular diseases
4. The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
5. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
6. Have received other similar drugs in the past;
7. Known history of allergy to HRS-1358 ingredients

Primary outcomes:
measure: Dose Limited Toxicities (DLTs)
timeFrame: up to 28 days
measure: Maximum tolerated dose
timeFrame: up to 28 days
measure: RP2D
timeFrame: Change From Baseline at 28 days
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: up to 30 days after the last dose
Secondary outcomes:
measure: Cmax
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Tmax
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: AUC0-t
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Cmax,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Tmax,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Cmin,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: AUCss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Rac
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
measure: Overall response rate (ORR) in participants
timeFrame: Up to approximately 1 year
measure: Clinical benefit rate (CBR) in participants
timeFrame: Up to approximately 1 year
measure: Duration of response (DOR) in participants
timeFrame: Up to approximately 1 year
measure: Progression Free Survival (PFS) observed in participants
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References: