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Phase Ib/II Study of Fluzoparib in Combination With Dalpiciclib in Patients With Locally Advanced or Metastatic Sarcoma

NCT05952128 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-19

No results posted yet for this study

Summary

This is a single-center, single-arm phase Ib / II clinical trial, which was included with two phase. The main purpose of the phase Ib part was to determine the dose-limiting toxicity ( DLT ), maximum tolerated dose ( MTD ), and recommended dose ( RP2D ) of Fluzoparib combined with Dalpiciclib in patients with locally advanced or metastatic sarcoma. The phase II part is mainly to observe the efficacy and safety of Fluzoparib combined with Dalpiciclib.

Conditions

  • Sarcoma

Interventions

DRUG

Fluzoparib+ Dalpiciclib

Drug Fluzoparib 100mg bid PO qd, administered continuously until disease progression, unacceptable toxicity or death. 28 days as a treatment cycle. Other names: SHR-3162 Drug Dalpiciclib 100mg/125mg/150mg PO qd, administered only from day1 to day 21 every cycle until disease progression, unacceptable toxicity or death. 28 days as a treatment cycle. Other names: SHR-6390

Sponsors & Collaborators

  • Jiangsu Hengrui Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-01
Completion
2025-12-01

Countries

  • China

Study Locations

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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 NCT05952128 on ClinicalTrials.gov