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

NCT05349409 | Unknown Phase 2

• 1 other identifier: SHR-A1811-Ⅱ-201
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose Limited Toxicity

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

  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

  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

  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 (15)

• DoR

  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

  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

  from the date of the first dose to the date of treatment termination, up to 6 months

• PFS

  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

• OS

  from the date of the first dose to the date of death for any reason, up to 100 months

Study Arms (1)

Treatment group

EXPERIMENTAL

SHR-A1811, Fluzoparib

Drug: SHR-A1811; Drug: Fluzoparib Capsule

Interventions

SHR-A1811 DRUG

SHR-A1811 for Injection: Given IV.

Treatment group

Fluzoparib Capsule DRUG

Fluzoparib Capsule: Given PO.

Also known as: SHR-3162

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 410013, China

Location

MeSH Terms

Interventions

fluzoparib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-A1811 for Injection in combination with Fluzoparib Capsule.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: June 9, 2022
• Primary Completion: November 30, 2024
• Study Completion: May 31, 2025
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CN (2)