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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

NCT ID: NCT04993430

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-26

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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ER-Positive, HER2-Negative Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

HRS8807 monotherapy and in combination with SHR6390
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

HRS8807 monotherapy dose escalation

Group Type EXPERIMENTAL

HRS8807

Intervention Type DRUG

HRS8807 monotherapy

Group B

HRS8807 monotherapy dose expansion

Group Type EXPERIMENTAL

HRS8807

Intervention Type DRUG

HRS8807 monotherapy

Group C

HRS8807 in combination with SHR6390 dose escalation

Group Type EXPERIMENTAL

HRS8807、SHR6390

Intervention Type DEVICE

HRS8807 in combination with SHR6390

Group D

HRS8807 in combination with SHR6390 dose expansion

Group Type EXPERIMENTAL

HRS8807、SHR6390

Intervention Type DRUG

HRS8807 in combination with SHR6390

Interventions

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HRS8807

HRS8807 monotherapy

Intervention Type DRUG

HRS8807

HRS8807 monotherapy

Intervention Type DRUG

HRS8807、SHR6390

HRS8807 in combination with SHR6390

Intervention Type DEVICE

HRS8807、SHR6390

HRS8807 in combination with SHR6390

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjie Xin

Role: CONTACT

Phone: +0518-81220121

Email: [email protected]

Facility Contacts

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Jiong Wu, Doctor

Role: primary

Jian Zhang

Role: backup

Other Identifiers

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HRS8807-I-101

Identifier Type: -

Identifier Source: org_study_id