A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer

A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer

To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: SHR-A1811；Pertuzumab; Drug: SHR-A1811；Albumin paclitaxel; Drug: SHR-A1811：Pyrotinib; Drug: SHR-A1811；Adebrelimab

• Study Type: Interventional
• Enrollment (Estimated): 402
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoxue Pi; Phone Number: 0518-82342973; Email: Xiaoxue.pi@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Provincial People's Hospital
      • Principal Investigator: Jinhai Tang
      • Principal Investigator: Yongmei Yin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. Breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. Presence with uncontrollable third space effusion
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
6. Any active autoimmune disease or a history of autoimmune disease
7. A history of immune deficiency
8. Clinically significant cardiovascular disorders
9. Clinically significant history of lung disease
10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
11. Known hereditary or acquired bleeding tendency
12. Active hepatitis and liver cirrhosis
13. Presence of other serious physical or mental diseases or laboratory abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A1811combined Pyrotinib	Drug: SHR-A1811：Pyrotinib; SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral
Experimental: SHR-A1811Combined Pertuzumab	Drug: SHR-A1811；Pertuzumab; SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
Experimental: SHR-A1811Combined Albumin-bound Paclitaxel	Drug: SHR-A1811；Albumin paclitaxel; SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip
Experimental: SHR-A1811Combined Adebrelimab	Drug: SHR-A1811；Adebrelimab; SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DLT（Phase I (dose exploration phase) ）	21 days after the first administration of each subject
AE（Phase I (dose exploration phase) ）	from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）	from Day1 to 40 or 90 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）	Two years after the last subject was enrolled in the group

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）	through study completion, an average of 2 years
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）	through study completion, an average of 2 years
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）	through study completion, an average of 2 years
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）	through study completion, an average of 2 years
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）	through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase I secondary endpoint）	through study completion, an average of 2 years
Objective Response Rate（Phase I secondary endpoint）	from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response（Phase I secondary endpoint）	from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase I secondary endpoint）	from first dose to disease progression or death, whichever comes first, up to 3 years
AE（Phase II secondary study endpoint）	from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）	from Day1 to 40 or 90 days after last dose
PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）	through study completion, an average of 2 years
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）	through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）	through study completion, an average of 2 years
Duration of response（Phase II secondary study endpoint）	from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase II secondary study endpoint）	from first dose to disease progression, or death, whichever comes first, up to 3 years
Event-Free Survival Rate（Phase II secondary study endpoint）	from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）	through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase I secondary endpoint）	through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）	through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Paclitaxel; Pertuzumab
• Other Study ID Numbers: SHR-A1811-II-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No