A Multicenter, Non-randomized, Open-label, Multiple-Dose Phase I Study of NWY001, in Subjects With Advanced Solid Tumors

Chipscreen Biosciences, Ltd.1 site in 1 country196 target enrollmentJanuary 5, 2024

ConditionsAdvanced Solid Tumor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumor
Sponsor: Chipscreen Biosciences, Ltd.
Enrollment: 196
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts:

Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part

Detailed Description

Part 1: Patients with advanced solid tumors that has relapsed from or is refractory to standard therapy or for which no standard therapy exists will be enrolled in different cohorts. Part 2: Recommended Phase 2 dose (RP2D) of NWY001 will be given to all patients enrolled in this part.

Registry

clinicaltrials.gov

Start Date

January 5, 2024

End Date

May 2028

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Chipscreen Biosciences, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willingness to sign a written informed consent document
•Participant with advanced solid malignant tumor that has relapsed from or is refractory to standard therapy or for which no standard therapy exists
•18\~75 years of age at the time of screening
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Life expectancy ≥3 months
•Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF, erythropoietin, and blood transfusion, within 14 days before first dose):
•absolute neutrophil count (ANC) ≥1.5×109/L 2) platelet ≥100×109/L 3) hemoglobin ≥90 g/L 4) creatinine clearance \>50 mL/min (according to Cockcroft-Gault equation) 5) both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal (ULN) (≤5×ULN for patients with hepatic metastasis) 6) total bilirubin ≤1.5×ULN (≤3×ULN for patients with gilbert syndrome) 7) international normalized ratio (INR) \<2.0, activated partial thromboplastin time (aPTT) ≤1.5×ULN
•Prior anti-cancer therapy meets the following criteria:
•major surgery ≥4 weeks
•radiotherapy ≥4 weeks

Exclusion Criteria

•Current or previous history of other active aggressive malignancies in the last 5 years, except :
•previous history of non-aggressive malignancies, such as cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast that remains in complete remission for years after curative treatment
•malignancies with negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and focal prostate cancer)
•Current or previous history of hematological malignancies
•Primary central nervous system (CNS) malignancies or CNS metastases
•History of allergy or hypersensitivity to monoclonal antibodies or excipients, or a known history of allergy to antibodies produced by Chinese hamster ovary cell
•Uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal medications
•History of clinically significant lung diseases (such as interstitial pneumonia, pneumonia, pulmonary fibrosis, and severe radiation pneumonia), or patients suspected of having these diseases on radiographic examination during the screening period
•Uncontrolled complications, including, but not limited to, persistent active infections, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled chest and abdominal fluid accumulation, psychiatric disorders that do not meet study requirements, and other serious conditions requiring systemic treatment
•Known history of HIV, active infections of hepatitis B or hepatitis C

Outcomes

Primary Outcomes

Dose-limiting toxicity (DLT)

Time Frame: Up to 21 days

Number of patients experienced any dose limited toxicity

Incidence of adverse events (AEs)

Time Frame: Until 30 days after the last dose of the study drug

Number of patients experienced AEs

Secondary Outcomes

Disease control rate (DCR)(Until 30 days after the last dose of the study drug)
Progression free survival (PFS)(Until 30 days after the last dose of the study drug)
Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)(From pre-dose to 30 days after the last dose of the study drug)
Tumor necrosis factor-α (TNF-α)(From pre-dose to 30 days after the last dose of the study drug)
Interleukin-6 (IL-6)(From pre-dose to 30 days after the last dose of the study drug)
Incidence of neutralizing antibody (NAb)(From pre-dose to 30 days after the last dose of the study drug)
Objective response rate (ORR)(Until 30 days after the last dose of the study drug)
Incidence of anti-drug antibody (ADA)(From pre-dose to 30 days after the last dose of the study drug)
Maximum plasma concentration (Cmax)(From pre-dose to 30 days after the last dose of the study drug)
Time to Cmax (Tmax)(From pre-dose to 30 days after the last dose of the study drug)