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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

NCT04993430 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-16

No results posted yet for this study

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

Interventions

DRUG

HRS8807

HRS8807 monotherapy

DRUG

HRS8807

HRS8807 monotherapy

DEVICE

HRS8807、SHR6390

HRS8807 in combination with SHR6390

DRUG

HRS8807、SHR6390

HRS8807 in combination with SHR6390

Sponsors & Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04993430 on ClinicalTrials.gov