Clinical trial · Interventional
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib Capsule | Drug | — | UNRESOLVED |
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- SHR-A1811, Fluzoparib
- interventionNames
- Drug: SHR-A1811
- Drug: Fluzoparib Capsule
Primary outcomes (3)
- measure
- Dose Limited Toxicity
- timeFrame
- first dose of study medication up to 21 days
- description
- Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
- measure
- Recommended phase II dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available