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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Invitation-only; Phase 2

Conditions: Advanced Solid Tumors

Treatments: Drug: Fluzoparib Capsule; Drug: SHR-A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT05349409

SHR-A1811-Ⅱ-201

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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212 participants in 1 patient group

Treatment group

Experimental group

Description:

SHR-A1811, Fluzoparib

Treatment:

Drug: SHR-A1811

Drug: Fluzoparib Capsule