Actively Recruiting
A Study of NWY001 in Subjects With Advanced Solid Tumors
Led by Chipscreen Biosciences, Ltd. · Updated on 2024-07-16
196
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of NWY001 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to sign a written informed consent document
- Diagnosis of advanced solid malignant tumor relapsed from or refractory to standard therapy or with no standard therapy
- Age between 18 and 75 years at screening
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Laboratory values meeting specified thresholds without recent corrective treatments
- Prior anti-cancer therapies completed within defined timeframes before first dose
- At least one measurable target lesion as defined by RECIST1.1
- For Part 2a, histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 status as specified
- For Part 2b, histologically confirmed advanced esophageal squamous carcinoma
- For Part 2c, histologically confirmed advanced pancreatic ductal adenocarcinoma
- For Part 2d, histologically confirmed advanced hepatocellular carcinoma
- For Part 2e, histologically confirmed advanced intrahepatic cholangiocarcinoma
- For Part 2f, histologically confirmed advanced MSI-H/dMMR colorectal cancer
You will not qualify if you...
- Current or previous active aggressive malignancies within the last 5 years except certain non-aggressive or low-risk cancers
- Current or previous history of hematological malignancies
- Primary central nervous system malignancies or metastases
- Allergy or hypersensitivity to monoclonal antibodies or related substances
- Uncontrolled infections requiring intravenous treatment
- History or suspicion of significant lung diseases
- Uncontrolled medical complications including infections, coagulopathy, cardiovascular or immune diseases, diabetes, fluid accumulation, or psychiatric disorders
- Known HIV infection or active hepatitis B or C infections
- Active pulmonary tuberculosis, unless negative on specific tests
- Women who are pregnant, breastfeeding, or intending pregnancy during the study
- Participants of childbearing potential refusing effective contraception during and after the study treatment period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Cancer
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xinhao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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