Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial.
Shukui Qin, Jin Li, Haijun Zhong...
https://pubmed.ncbi.nlm.nih.gov/36261583Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID03941574
A Single-arm, Multi-center Phase II Study to Evaluate HLX10 Monotherapy for Unresectable or Metastatic MSI-H or dMMR Solid Tumors That Failed Standard Therapy
Led by Shanghai Henlius Biotech · Updated on 2022-10-28
108
Participants Needed
33
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HLX10 monotherapy in patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have not responded to standard treatments. This phase II, single-arm, open-label, multicenter study aims to assess the clinical efficacy and safety of HLX10 in this group of patients who have experienced disease progression or intolerable side effects from prior therapies. Participants will receive HLX10 as an intravenous infusion at a dose of 3 mg/kg every two weeks. Treatment will continue until loss of clinical benefit, death, unacceptable toxicity, withdrawal, or for up to two years (52 dosing periods), whichever happens first. The study includes a screening period of 28 days before treatment, followed by the treatment phase and a follow-up period that covers both safety and survival monitoring. During the study, patients will undergo assessments including tumor measurements and clinical evaluations. Tumor tissue and blood samples will be collected to analyze markers like MSI, tumor mutational burden, and PD-L1 expression. Safety follow-up and survival will be monitored throughout the study duration. The primary outcome measure is the objective response rate (ORR) assessed up to two years, along with secondary outcomes such as overall survival, progression-free survival, and duration of response.
CONDITIONS
Brief 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
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Volunteers willing to participate and able to complete all study procedures
- Age between 18 and 75 years at consent
- Diagnosed with unresectable or metastatic MSI-H or dMMR malignant solid tumors confirmed by pathology
- Disease progression or intolerable reactions after standard anti-cancer treatment
- At least 2 weeks since last systemic anti-tumor treatment with recovery from treatment-related adverse events to grade 1 or less (excluding grade 2 alopecia)
- At least one measurable lesion per RECIST v1.1, excluding prior radiotherapy sites unless specific imaging data provided
- Provide tumor tissue and blood samples for MSI, tumor mutational burden, and PD-L1 testing
- ECOG performance status of 0 or 1 within 7 days before first dose
- Life expectancy of at least 12 weeks
- Negative hepatitis B surface antigen or negative HBV DNA if positive
- Negative hepatitis C antibody or low liver enzymes if positive, no concurrent hepatitis B and C
- Normal main organ function and no recent blood transfusions or certain treatments
- Female participants must be menopausal, surgically sterile, or agree to effective contraception and not breast-feeding
- Male participants must agree to effective contraception or sexual abstinence during and after treatment
You will not qualify if you...
- History or planned organ or bone marrow transplantation
- Uncontrolled pleural, pericardial effusion, or ascites
- Active central nervous system metastasis or carcinomatous meningitis, except stable or asymptomatic brain metastasis under defined conditions
- Untreated or unstable spinal cord compression
- Tumor invasion of thoracic great vessels
- Recent myocardial ischemia, infarction, unstable angina, or uncontrolled arrhythmia
- Severe cardiac dysfunction (NYHA grade 2 or 3) or low ejection fraction
- Peripheral neuropathy grade 2 or higher
- HIV infection
- Active pulmonary tuberculosis
- Lung conditions interfering with toxicity detection or treatment
- Active or suspected autoimmune diseases requiring systemic immunosuppression
- Recent live vaccine use
- Need for systemic corticosteroids or immunosuppressive therapy above allowed limits
- Active infection requiring systemic treatment
- Major surgery within 28 days before study drug
- Recent radical radiotherapy within 3 months (except allowed palliative radiotherapy)
- Concurrent other anti-tumor treatments during study
- Previous treatment with certain immune checkpoint inhibitors or related drugs
- Participation in another clinical study with less than 14 days interval
- Known serious hypersensitivity to monoclonal antibodies or study drug components
- Pregnant or lactating women
- History of psychotropic drug abuse or drug addiction
- Other factors that could cause early study termination at investigator's discretion
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants receive HLX10 monotherapy through intravenous injection as the active treatment for unresectable or metastatic MSI-H or dMMR solid tumors that failed standard therapy.
Regular dosing visits as per protocol schedule
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
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Research Team
S
ShuKui Qin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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