Status:
NOT_YET_RECRUITING
PARP Inhibitor CVL218 in Combination Therapy for Patients With Advanced Solid Tumors
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to evaluate the efficacy of CVL218 in combination with Toripalimab injection/Sintilimab injection (Darbersol, Sintilimab) in the treatment of advanced solid tumors. It focuses on asses...
Detailed Description
This Phase Ib/II clinical study is designed to determine the recommended Phase II dosage of the combination therapy and its initial efficacy. The study consists of two phases: an exploratory phase (Ib...
Eligibility Criteria
Inclusion
- 1\. Patients between the ages of 18 and 75 (including those aged 18 and 75, and those over 60 years old should not suffer from more than 3 complications of heart, lung, liver and kidney function at the same time), regardless of gender.
- 2\. Patients with locally advanced or metastatic advanced solid tumors confirmed by histology or cytology (including but not limited to triple-negative breast cancer, gastric cancer, colorectal cancer); Patients with ≤1 line of standard treatment failure (disease progression after treatment or intolerability of toxic side effects of treatment), or no standard treatment, or unable to receive standard treatment.
- 3\. In stage II, patients with positive PD-L1 molecular expression level combined with CPS≥1 were required to be enrolled, or there was evidence of harmful HRD gene variants (BRCA1, BRCA2, PALB2, ATM, CHEK2 variants, etc.).
Exclusion
- Chemotherapy, radiotherapy, biotherapy and endocrinology were received within 4 weeks before the first administration
- Treatment, immunotherapy and other antitumor drugs, except the following:
- Nitrosourea or mitomycin C within 6 weeks before first use of the study drug;
- Oral fluorouracil and small molecule targeted drugs are used before first investigational drugs
- 2 weeks or within 5 half-lives of the drug, whichever is longer;
- Traditional Chinese medicines with anti-tumor indications were used within 2 weeks before the first use of study drugs.
- 2\. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to initial administration
- Therapy.
- 3\. Received major organ surgery (excluding puncture) within 4 weeks prior to initial administration
- Biopsy) or significant trauma.
- 4\. Received systemic glucocorticoids (strong) within 14 days prior to initial administration
- Pine \> 10mg/ day or equivalent dose of similar drugs) or other immunosuppressant
- Treatment;
- Except in the following cases: topical, ocular, intraarticular, intranasal, and inhalation
- Type I glucocorticoid therapy; Short-term use of corticosteroids for prophylactic treatment (eg to prevent contrast allergy).
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06078670
Start Date
October 10 2023
End Date
June 1 2026
Last Update
October 12 2023
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