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

NCT04993430 | Unknown Phase 1

• 1 other identifier: HRS8807-I-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

ER-Positive, HER2-Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• MTD

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

  Change From Baseline at 28 days

• RP2D

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

  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 \[NCI CTCAE version 5.0\]).

  Up to 30 days after end of treatment

Secondary Outcomes (23)

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

  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

  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

  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

  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

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

Study Arms (4)

Group A

EXPERIMENTAL

HRS8807 monotherapy dose escalation

Drug: HRS8807

Group B

EXPERIMENTAL

HRS8807 monotherapy dose expansion

Drug: HRS8807

Group C

EXPERIMENTAL

HRS8807 in combination with SHR6390 dose escalation

Device: HRS8807、SHR6390

Group D

EXPERIMENTAL

HRS8807 in combination with SHR6390 dose expansion

Drug: HRS8807、SHR6390

Interventions

HRS8807 DRUG

HRS8807 monotherapy

Group A

HRS8807、SHR6390 DEVICE

HRS8807 in combination with SHR6390

Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
• Expected survival of more than 3 months.

You may not qualify if:

• All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
• Presence of symptomatic metastatic visceral disease ;
• Patients with known active brain metastases;
• Clinically serious cardiovascular disease;
• Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
• Abnormal thyroid function laboratory results;
• Active infection or unexplained fever \>38.5℃ during screening period or on the day of the first dose.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Wenjie Xin

CONTACT

+0518-81220121; Wenjie.xin@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS8807 monotherapy and in combination with SHR6390

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 6, 2021
• Study Start: October 26, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

CN (1)