Actively Recruiting
A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-05-31
214
Participants Needed
13
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of consent
- Patients with advanced malignancies confirmed by tissue diagnosis
- For single-agent dose phases: patients with advanced tumors who have failed or cannot tolerate standard treatments or have no standard options
- For specific cancers in single-agent expansion phase, prior treatment requirements such as progression after PD-(L)1 antibody and platinum chemotherapy for NSCLC and melanoma, PD-L1 positive status for colorectal cancer, prior targeted and PD-(L)1 therapy for RCC, and other advanced malignancies failing standard treatment
- For combination therapy phase, patients with specific cancer types including NSCLC, colorectal cancer, RCC, melanoma, HCC, and other advanced malignancies meeting defined prior treatment and progression criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Good organ function
- Fertile participants must agree to effective contraception during study and 6 months after last dose; negative pregnancy test required for women of childbearing potential
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Receipt of chemotherapy, immunotherapy, investigational drugs within 21 days or oral fluorouracil, small molecule targeted drugs, or Chinese anti-tumor medicines within 14 days before first dose
- Major surgery or radiotherapy within 28 days before first dose, except allowed palliative radiotherapy or minor procedures
- Systemic corticosteroids over 10 mg prednisone per day or immunosuppressants within 2 weeks before first dose (some topical or low-dose steroids allowed)
- Active central nervous system metastases or recent unstable brain metastases; meningeal or brainstem metastases excluded
- Previous immune-related adverse events causing permanent immunotherapy discontinuation
- Symptomatic pleural, abdominal, or pericardial effusions requiring repeated treatment
- History or active interstitial lung disease or pneumonia requiring corticosteroids
- Severe, unhealed wounds, active ulcers, or untreated fractures
- Bleeding disorders or severe coagulation problems
- Poorly controlled hypertension or history of hypertensive crisis
- Unresolved toxicities from prior cancer treatments beyond grade 1 unless well controlled
- Severe infections within 28 days or active infections requiring IV therapy within 2 weeks before dosing
- Significant recent bleeding or tumor-related bleeding within 1 month before dosing
- Gastrointestinal perforation, fistula, abscess, bleeding, or definite bleeding tendency within 6 months before randomization
- Severe cardiovascular or cerebrovascular diseases including recent major heart events or low heart function
- Active autoimmune diseases requiring systemic treatment within 2 years, with some exceptions
- History of other cancers within 5 years except certain cured local tumors
- Active tuberculosis or certain viral infections including hepatitis B, C, or HIV
- Immunodeficiency or history of organ or stem cell transplantation
- Other serious physical or mental conditions that may increase risk or affect study compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
4
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471099
Not Yet Recruiting
5
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
7
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
8
The First Hospital of Jilin University
Changchun, Jilin, China
Not Yet Recruiting
9
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
10
The First Hospital of China Medical University
Shenyang, Liaoning, China, 400042
Actively Recruiting
11
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
12
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
13
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
X
Xiaohong Ding, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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