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A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT05585281 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-28

No results posted yet for this study

Summary

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.

Conditions

Interventions

DRUG

Fluzoparib

Fluzoparib Orally twice daily

BIOLOGICAL

QL1101

Maintenance QL1101 7.5 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. QL1101 will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of QL1101 received with chemotherapy.

Sponsors & Collaborators

  • Yongpeng Wang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2025-11-07
Completion
2025-12-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585281 on ClinicalTrials.gov