Clinical trial NCT05349409: A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
Official title: A Phase Ⅰb/Ⅱ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-A1811 for Injection in combination with Fluzoparib Capsule.
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥18 years at the time of signing the ICF.
2. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
3. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
4. Life expectancy ≥12 weeks.
5. Adequate organ functions as defined.
6. Swallow the drug pills normally.

Exclusion Criteria:

1. patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy.
2. Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
3. Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
4. History of autoimmune diseases.
5. Not well controllable and serve cardiovascular disease.
6. Prior lung disease with clinical significance.
7. Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation.
8. Active Hepatitis B and Hepatitis C; or serve infection with medication control.
9. The grade of toxicity from the prior anti-cancer therapy not decrease to ≤ 1.
10. Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.

Primary outcomes:
measure: Dose Limited Toxicity
timeFrame: first dose of study medication up to 21 days
measure: Recommended phase II dose
timeFrame: first dose of study medication up to 21 days
measure: ORR
timeFrame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Secondary outcomes:
measure: DoR
timeFrame: from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: DCR
timeFrame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: TTR
timeFrame: from the date of the first dose to the date of treatment termination, up to 6 months
measure: PFS
timeFrame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: OS
timeFrame: from the date of the first dose to the date of death for any reason, up to 100 months
measure: 12 months' survival rate
timeFrame: from the date of the first dose up to 12 months
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
measure: The occurrence rate of dose titration due to AE related with study medication
timeFrame: from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
measure: Cmin
timeFrame: 10 min before first dose of Fluzoparib Capsule in C1D8 to 10 min before first dose of Fluzoparib Capsule in C8D1
measure: C3h
timeFrame: 3 hour after first dose of Fluzoparib Capsule in C2D1
measure: AUC0-t
timeFrame: the date of first dose to 30 days after last dose
measure: Cmin
timeFrame: the date of first dose to 30 days after last dose
measure: Cmax
timeFrame: the date of first dose to 30 days after last dose
measure: ADA
timeFrame: the date of first dose up to 90 days after last dose
measure: NAb
timeFrame: the date of first dose up to 90 days after last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: