Actively Recruiting
A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy
Led by Shanghai Henlius Biotech · Updated on 2022-10-28
108
Participants Needed
33
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol, or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).
CONDITIONS
Official Title
A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer willing to participate, understand the study, sign informed consent, and complete all study procedures
- Age between 18 and 75 years at time of consent
- Confirmed unresectable or metastatic MSI-H or dMMR malignant solid tumors
- Disease progression or intolerable reactions after standard anti-cancer treatments
- At least 2 weeks since last systemic anti-tumor treatment with recovered related side effects to grade 1 or less (excluding grade 2 alopecia)
- At least one measurable lesion by RECIST version 1.1, not from previous radiotherapy sites unless imaging data confirms progression
- Provide tumor tissue and blood samples for MSI, tumor mutational burden, and PD-L1 testing as required
- ECOG performance status of 0 or 1 within 7 days before first dose
- Life expectancy of at least 12 weeks
- Negative for hepatitis B surface antigen or negative HBV DNA if positive HBsAg or HBcAb
- Negative for hepatitis C antibody or controlled liver enzymes if positive HCV markers; no concurrent hepatitis B and C
- Normal main organ function without recent blood transfusions or growth factor treatments
- Female subjects must be menopausal, surgically sterilized, or have negative pregnancy test and agree to effective contraception or abstinence during and 120 days after treatment; breastfeeding not allowed
- Male subjects must agree to abstinence or use contraception during and 120 days after treatment
You will not qualify if you...
- Planned or previous organ or bone marrow transplantation
- Uncontrollable pleural, pericardial effusion, or ascites
- Active CNS metastasis or carcinomatous meningitis except stable or asymptomatic brain metastases under specified conditions
- Untreatable spinal cord compression or unstable prior compression
- Tumor invasion of thoracic great vessels
- Recent significant heart events or uncontrolled arrhythmias within 6 months
- Severe cardiac dysfunction or low left ventricular ejection fraction
- Peripheral neuropathy grade 2 or higher
- HIV infection
- Active pulmonary tuberculosis
- Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function
- Active or suspected autoimmune diseases requiring systemic immunosuppressive therapy
- Live vaccines within 28 days before first dose
- Systemic corticosteroids or immunosuppressive therapy within 14 days before or during study, except some allowed inhaled or topical steroids
- Active infections requiring systemic treatment within 14 days before first dose
- Major surgery within 28 days before first dose (excluding tumor puncture or biopsy)
- Radical radiotherapy within 3 months before first dose, except some allowed palliative radiotherapy
- Use of other anti-tumor therapies during study
- Prior treatment with T cell co-stimulation or immune checkpoint inhibitors
- Participation in another clinical trial with less than 14 days since last investigational product
- History of serious hypersensitivity to monoclonal antibodies or study drug components
- Pregnant or lactating women
- History of psychotropic drug abuse or drug addiction (except former drinkers)
- Other factors risking premature study termination at investigator's discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
2
Peking University International Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
4
the 900th Hospital of Joint Logistic Support Force
Fuzhou, Fujian, China, 35002
Actively Recruiting
5
Zhongnan Hospital of Wuhan University
Wuhan, Fujian, China, 430062
Actively Recruiting
6
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
7
First People's Hospital of Fushan
Fushan, Guangdong, China, 528010
Actively Recruiting
8
The First Affiliated Hospital and Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510075
Actively Recruiting
9
The First Affiliated Hospital (School of Clinical Medicine), Guangdong Pharmaceutical University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
10
Affiliated Cancer Hospital & Institute, Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Actively Recruiting
11
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
12
Affiliated Hospital of Guangdong Medical University
Zhenjiang, Guangdong, China, 510180
Actively Recruiting
13
Zhongshan city People's Hospital
Zhongshan, Guangdong, China, 528404
Actively Recruiting
14
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
15
The People's Hospital of Guangxi Zhuangzu Autonomous Region
Nanning, Guangxi, China, 530016
Actively Recruiting
16
Fourth Hospital of Hebei Medical University,
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
17
Harbin Medical University Cancer Hospital,
Harbin, Heilongjiang, China, 150040
Actively Recruiting
18
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
19
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 200065
Actively Recruiting
20
The Third Xiangya Hospital, Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
21
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
22
Qinhuai Medical District, General Hospital of the eastern theater of the Chinese people's Liberation Army
Nanjing, Jiangsu, China, 210002
Actively Recruiting
23
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116023
Actively Recruiting
24
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
25
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
26
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
27
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
28
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China
Chengdu, Sichuan, China, 610041
Actively Recruiting
29
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
30
Tianjin Medical University Cancer Institue and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
31
Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center
Kunming, Yunnan, China, 650118
Actively Recruiting
32
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
33
Taizhou first people's Hospital
Taizhou, Zhejiang, China, 318020
Actively Recruiting
Research Team
S
ShuKui Qin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here