A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT06308406
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab； HRS-1167 — DRUG
    Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet, oral

Study Details

This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer.

Key Dates

First listed
Mar 13, 2024
Start date
Mar 15, 2024
Status verified
Feb 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer

Primary Outcome Measure

The number of subjects with dose-limiting toxicity (DLT) [ Time Frame: From first dose of study treatment until the end of Cycle 1（up to 21 days） ]

Central Contacts

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