A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

NCT05792410 | Unknown Phase 1

• 1 other identifier: SHR-A1811-206
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.

Conditions

HER2 Low Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (4)

• DLT(Phase I (dose-finding phase) main study endpoint)

  At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.

• AE(Phase I (dose-finding phase) main study endpoint)

  Up to follow-up period, approximately 24 months

• Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)

  Up to follow-up period, approximately 24 months

• Objective response rate(The main end points of the second stage (efficacy expansion stage))

  Until progression, assessed up to approximately 24 months

Secondary Outcomes (6)

• SHR-A1811 sparse PK concentrations in serum

  While on study drug up to study completion, approximately 24 months

• Dalpiciclib sparse PK concentrations in plasm

  While on study drug up to study completion, approximately 24 months

• Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time

  Up to follow-up period, approximately 24 months

• Incidence of neutralizing antibody (NAb) to SHR-A1811 over time

  Up to follow-up period, approximately 24 months

• Duration of response (DoR)

  Until progression or death, assessed up to approximately 24 months

Study Arms (3)

SHR-A1811 combined with Dalpiciclib Isethionate Tablets

EXPERIMENTAL

Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets

SHR-A1811 combined with Fulvestrant

EXPERIMENTAL

Drug: SHR-A1811 & Fulvestrant

SHR-A1811 combined with Bevacizumab injection

EXPERIMENTAL

Drug: SHR-A1811 & Bevacizumab injection

Interventions

SHR-A1811 & Dalpiciclib Isethionate Tablets DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral

SHR-A1811 combined with Dalpiciclib Isethionate Tablets

SHR-A1811 & Fulvestrant DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular

SHR-A1811 combined with Fulvestrant

SHR-A1811 & Bevacizumab injection DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip

SHR-A1811 combined with Bevacizumab injection

Eligibility Criteria

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

You may qualify if:

• Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
• When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
• ECOG Performance Status of 0 or 1
• Patient must have adequate tumor sample for biomarker assessment
• At least one measurable lesion
• Adequate organ function

You may not qualify if:

• There are untreated or active central nervous system (CNS) tumor metastases
• There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
• Major surgery within 4 weeks prior to enrollment
• Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
• Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
• Uncontrolled intercurrent illness
• Uncontrolled or significant cardiovascular disease
• Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
• According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shuchao Wu

CONTACT

+0518-81220121; shuchao.wu@hengrui.com.cn

Study Design

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

Model Details: An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 31, 2023
• Study Start: April 1, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2025
• Last Updated: March 31, 2023

Record last verified: 2023-02