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

NCT05353361 | Unknown Phase 2

• 1 other identifier: SHR-A1811-II-202
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (21)

• 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

Study Arms (4)

SHR-A1811combined Pyrotinib

EXPERIMENTAL

Drug: SHR-A1811：Pyrotinib

SHR-A1811Combined Pertuzumab

EXPERIMENTAL

Drug: SHR-A1811；Pertuzumab

SHR-A1811Combined Adebrelimab

EXPERIMENTAL

Drug: SHR-A1811；Adebrelimab

SHR-A1811Combined Albumin-bound Paclitaxel

EXPERIMENTAL

Drug: SHR-A1811；Albumin paclitaxel

Interventions

SHR-A1811：Pyrotinib DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral

SHR-A1811combined Pyrotinib

SHR-A1811；Pertuzumab DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip

SHR-A1811Combined Pertuzumab

SHR-A1811；Adebrelimab DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip

SHR-A1811Combined Adebrelimab

SHR-A1811；Albumin paclitaxel DRUG

SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip

SHR-A1811Combined Albumin-bound Paclitaxel

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoxue Pi

CONTACT

0518-82342973; Xiaoxue.pi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, open-label, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration phase, which uses the 3 + 3 escalation design; The second stage is the curative effect expansion phase.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 29, 2022
• Study Start: May 23, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CN (1)