A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer

Shanghai Hengrui Pharmaceutical Co., Ltd.90 enrolled

Overview

The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects 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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ER-Positive, HER2-Negative Breast Cancer

Interventions

HRS8807DRUG

HRS8807 monotherapy

HRS8807DRUG

HRS8807 monotherapy

HRS8807、SHR6390DEVICE

HRS8807 in combination with SHR6390

HRS8807、SHR6390

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative; 2. At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 4. Expected survival of more than 3 months. Exclusion Criteria: 1. All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient; 2. Presence of symptomatic metastatic visceral disease ; 3. Patients with known active brain metastases; 4. Clinically serious cardiovascular disease; 5. Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement; 6. Abnormal thyroid function laboratory results; 7. Active infection or unexplained fever \>38.5℃ during screening period or on the day of the first dose.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

MTD

Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390

Time frame: Change From Baseline at 28 days

RP2D

select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390

Time frame: Change From Baseline at 28 days

Adverse events (AE) and serious AE (SAE)

AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 5.0\]).

Time frame: Up to 30 days after end of treatment

Secondary Outcomes

Tmax of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

Cmax of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

AUC0-t of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

AUC0-∞ of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

t1/2 of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

Central Contacts

Wenjie Xin

CONTACT

+0518-81220121 Wenjie.xin@hengrui.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

HRS8807 in combination with SHR6390

Vz/F of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

CL/F of HRS8807 and the major metabolite after single dose of HRS8807

Time frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)

Tmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Cmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Cmin,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Tmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 1, Day 2, each cycle is 28 days

Cmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 1, Day 2, each cycle is 28 days

AUC0-t of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 1, Day 2, each cycle is 28 days

Tmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Cmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Cmin,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

AUCss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Rac of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390

Time frame: Cycle 1 Day 14, Day 15, each cycle is 28 days

Objective Response Rate (ORR)

Time frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant

Duration of Response (DoR)

Time frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant

Progression Free Survival (PFS)

Time frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant