A Study of NWY001 in Subjects With Advanced Solid Tumors

NCT05979155 | Recruiting Phase 1

• 1 other identifier: NWY001-101
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Number of patients experienced any dose limited toxicity

  Up to 21 days

• Incidence of adverse events (AEs)

  Number of patients experienced AEs

  Until 30 days after the last dose of the study drug

Secondary Outcomes (10)

• Objective response rate (ORR)

  Until 30 days after the last dose of the study drug

• 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

• 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

Study Arms (2)

Study arm (multiple doses of NWY001)

EXPERIMENTAL

Part 1: dose-escalation of monotherapy NWY001

Biological: NWY001

Study arm (RP2D of NWY001)

EXPERIMENTAL

Part 2: dose-expansion of monotherapy NWY001

Biological: NWY001

Interventions

NWY001 BIOLOGICAL

Part 1: Participants will be given a single-dose of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.

Study arm (multiple doses of NWY001)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \~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
• endocrine therapy ≥2 weeks
• chemotherapy (including antibody) ≥3 weeks
• immunotherapy ≥4 weeks
• \. At least one measurable target lesion as defined by RECIST1.1
• \. For part 2a: Participant has a diagnosis of histologically confirmed advanced (unresectable) or metastatic gastric or gastroesophageal junction adenocarcinoma

You may not qualify if:

• \. 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
• \. Active pulmonary tuberculosis. Participants vaccinated with BCG vaccine may be false positive for PPD, and they could be enrolled if negative for IGRA
• \. Women who are pregnant or breastfeeding or intended to become pregnant during the study period
• \. Participants of childbearing potential who refuse to take highly effective contraceptive measures during the entire study treatment period and for 120 days after the last dose of study drug

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Cancer

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Ruihua Xu, Ph.D.

  Sun Yat-sen University Cancer Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhao Wang

CONTACT

+86 0755-36993550; xinhwang@chipscreen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 7, 2023
• Study Start: January 5, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)