Clinical trial NCT05671822: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Official title: A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.

The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.


Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 75, Male and female participants
2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
3. HER2 expression ;
4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
5. ECOG 0-1;
6. The expected survival ≥3 months;
7. Sufficient bone marrow and organ functions;

Exclusion Criteria:

1. There were ascites, pleural effusion and pericardial effusion that needed to be treated;
2. Major surgery was performed within 4 weeks;
3. Have active autoimmune disease or history of autoimmune disease;
4. Patients with interstitial pneumonia;
5. There was severe infection within 4 weeks before starting the study treatment;
6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
7. Serious cardiovascular and cerebrovascular diseases;
8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;

Primary outcomes:
measure: Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
timeFrame: Safety will be assessed for approximately 24 months from informed consent
measure: Phase II: Objective Response Rate (ORR)[
timeFrame: An average of approximately 12 months
Secondary outcomes:
measure: ORR（Phase Ib）
timeFrame: An average of approximately 12 months
measure: DoR（Phase Ib）
timeFrame: An average of approximately 18 months
measure: PFS（Phase Ib）
timeFrame: An average of approximately 18 months
measure: OS（Phase Ib）
timeFrame: An average of approximately 30 months
measure: DoR（Phase II）
timeFrame: An average of approximately 18 months
measure: PFS（Phase II）
timeFrame: An average of approximately 18 months
measure: OS（Phase II）
timeFrame: An average of approximately 30 months
measure: Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II）
timeFrame: Safety will be assessed for approximately 24 months from informed consent]
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, FuDan University
state: Shanghai
Study officials:
References: