A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients

NCT06788197 | Not Yet Recruiting Phase 1

• 1 other identifier: 2024-528
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.

Conditions

Breast Cancer; Locally Advanced or Metastatic Breast Cancer

Keywords

Breast Cancer; SHR-A1811; HS-10352

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) according to RECIST1.1 （SHR-A1811+fulvestrant group and HS-10352 group (Phase II)）

  ORR defined as the proportion of patients with the best overall response of complete response or partial response，as determined by the investigator according to RECIST v1.1

  Up to approximately 4 years

• Recommended Phase 2 dose (RP2D) (HS-10352 group (Phase Ib))

  From the first dose to the last dose of the first cycle defined as 28 days

Secondary Outcomes (6)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) （SHR-A1811 + fulvestrant group and HS-10352 group (Phase II)）

  Up to approximately 4 years

• Objective Response Rate (ORR) according to RECIST1.1 （HS-10352 group(Phase Ib)）

  Up to approximately 4 years

• Progression-Free Survival (PFS)（SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

  Up to 4 years

• Overall Survival (OS) （SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

  Up to 4 years

• Clinical Benefit Rate (CBR) （CR+ PR+ SD≥24weeks）（SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

  Up to 4 years

Study Arms (2)

SHR-A1811 + fulvestrant group

EXPERIMENTAL

Subjects will receive SHR-A1811 combined with fulvestrant therapy.

Drug: SHR-A1811+ Fulvestrant

HS-10352 group

EXPERIMENTAL

Subjects will receive SHR-A1811 combined with Fulvestrant and HS-10352 therapy.

Drug: SHR-A1811+ Fulvestrant+HS-10352

Interventions

SHR-A1811+ Fulvestrant DRUG

SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular

SHR-A1811 + fulvestrant group

SHR-A1811+ Fulvestrant+HS-10352 DRUG

SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular ； HS-10351 is administered orally

HS-10352 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥18 years and ≤75 years;
• ECOG Performance Status of 0 -2;
• Locally advanced/metastatic breast cancer not amenable to curative therapy
• Disease progression during treatment or within 12 months of completing adjuvant therapy ;
• No prior anti-cancer systemic therapy has been administered;
• Fasting blood glucose \< 126 mg/dL, and HbA1C \< 6.0%;
• Life expectancy of ≥3 months;
• Patients have at least one target lesion according to RECEST 1.1;
• Adequate function of major organs;
• Female patients who are either premenopausal or have not undergone surgical sterilization: during the treatment period and for at least 7 months after the final dose of study medication, agree to abstain from sexual activity or utilize effective contraceptive methods.
• Sign Informed Consent Form.

You may not qualify if:

• Breast cancer that has not been histologically confirmed;
• Inflammatory breast cancer;
• Participants ineligible for endocrine therapy due to any disease burden, as judged by the investigator;
• Meningeal metastasis or active parenchymal brain metastasis;
• Presence of diabetes symptoms, history of primary diabetes, gestational diabetes, steroid-induced diabetes, or other secondary diabetes;
• Prior anti-cancer systemic therapy has been administered;
• Use of investigational drugs within 4 weeks；
• Received immunotherapy, macromolecular targeted therapy, or other antitumor biologics within 4 weeks; or received endocrine therapy, chemotherapy, small molecule targeted drug therapy, or traditional Chinese medicine treatment with antitumor indications within 2 weeks;
• Received radical radiotherapy within 4 weeks, or received palliative radiotherapy within 2 weeks;
• Previously received antitumor treatment or radiotherapy for any malignancy, excluding malignancies such as cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;
• A history of other malignancies within the past 5 years, excluding cured cases of skin basal cell carcinoma and cervical carcinoma in situ;
• Prior anti-tumor treatment toxicities have not yet recovered to NCI CTCAE V5.0 grade ≤1 or baseline levels;
• A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Interstitial pneumonia/interstitial lung disease, or presence of moderate to severe pulmonary disease that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first administration of the study drug, as well as any autoimmune, connective tissue, or inflammatory diseases involving the lungs, or a history of total pulmonary resection surgery
• Presence of active hepatitis B, hepatitis C, liver cirrhosis, or severe infections requiring control with antibiotics, antiviral drugs, or antifungal medications;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhenzhen Liu, MD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu, MD

CONTACT

86-13603862755; liuzhenzhen73@126.com

Xiaosan Zhang, MD

CONTACT

86-15638167115; zxs_8112@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: SHR-A1811 + fulvestrant group: SHR-A1811+fulvestrant ； HS-10352 group: SHR-A1811+Fulvestrant+HS-10352

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 23, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share