A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers

Suzhou Suncadia Biopharmaceuticals Co., Ltd.212 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

Advanced Solid Tumors

Interventions

SHR-A1811DRUG

SHR-A1811 for Injection: Given IV.

Fluzoparib CapsuleDRUG

Fluzoparib Capsule: Given PO.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Dose Limited Toxicity

Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period

Time frame: first dose of study medication up to 21 days

Recommended phase II dose

The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period

Time frame: first dose of study medication up to 21 days

ORR

Objective Response Rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients in indication expansion period

Time frame: 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

DoR

Duration of response, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients

Time frame: 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

DCR

Disease control rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients

Time frame: 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

TTR

Data from ClinicalTrials.gov

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