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NCT06078670

PHASE1/PHASE2

PARP Inhibitor CVL218 in Combination Therapy for Patients With Advanced Solid Tumors

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

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 assessing the safety, tolerability, and pharmacokinetic profile of a three-drug combination regimen comprising albumin-bound paclitaxel injection (Kealil), paclitaxel injection (Taxol), and Fuquinitinib capsule (Aiutec, Fruquintinib).

Official title: Phase Ib/II Clinical Study of PARP Inhibitor CVL218 in Combination With Therapy in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-10-10

Completion Date

2026-06

Last Updated

2023-10-12

Healthy Volunteers

Conditions

Advanced Solid Tumor

Interventions

DRUG

CVL218

Arm1: Triple negative breast cancer CVL218 is administered orally Triplelizumab injection was administered intravenously (IV) 240mg on D1 Paclitaxel injection (Kealil) 125mg /m2, D1, D8 administration Every 21 days for a drug cycle; Arm2: Gastric cancer CVL218 is administered orally Sindilizumab injection was given intravenously (IV) 200mg on D1 Paclitaxel injection (Taxol) 175mg /m2, D1 administration Every 21 days for a drug cycle; Arm3: Intestinal cancer CVL218 is administered orally Sindilizumab injection was given intravenously (IV) 200mg on D1 Fuquinitinib capsule 5mg QD orally, D1-14 administration Every 21 days is a medication cycle.

Inclusion Criteria: * 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 Criteria: * 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).