A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
- 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.
- Short title
- A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-12-31
- First posted
- 2022-04-29
- Registry last updated
- 2023-09-15
- Primary completion date
- 2025-12-31
- Start date
- 2022-05-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05353361
- ClinicalTrials.gov ID
- NCT05353361
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
DLT（Phase I (dose exploration phase) ）
Timeframe: 21 days after the first administration of each subject
AE（Phase I (dose exploration phase) ）
Timeframe: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）
Timeframe: from Day1 to 40 or 90 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Timeframe: Two years after the last subject was enrolled in the group
PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase I secondary endpoint）
Timeframe: through study completion, an average of 2 years
Objective Response Rate（Phase I secondary endpoint）
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response（Phase I secondary endpoint）
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase I secondary endpoint）
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
AE（Phase II secondary study endpoint）
Timeframe: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Timeframe: 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）
Timeframe: through study completion, an average of 2 years
PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）
Timeframe: through study completion, an average of 2 years
PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）
Timeframe: through study completion, an average of 2 years
Immunogenicity of SHR-A1811（Phase II secondary study endpoint）
Timeframe: through study completion, an average of 2 years
Immunogenicity of Adebrelimab（Phase II secondary study endpoint）
Timeframe: through study completion, an average of 2 years
Duration of response（Phase II secondary study endpoint）
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression Free Survival（Phase II secondary study endpoint）
Timeframe: from first dose to disease progression, or death, whichever comes first, up to 3 years
Event-Free Survival Rate（Phase II secondary study endpoint）
Timeframe: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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
- 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
- Jiangsu Provincial People's HospitalNanjing, ChinaRecruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Breast cancer Primary condition
- Breast neoplasm