Actively Recruiting
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2024-08-05
364
Participants Needed
15
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.
CONDITIONS
Official Title
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and cooperate with follow-up visits
- Age between 18 and 75 years at consent
- Male or female
- ECOG performance status 0-1
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed metastatic or advanced unresectable HER2-expressing or HER2 functional mutation solid tumors
- Provide 6 or more sections of tumor tissue samples obtained within 1 year before treatment or freshly obtained
- At least 1 measurable lesion per RECIST version 1.1 (dose escalation phase allows absence of measurable lesions)
- Organ function meeting criteria within 7 days before treatment start, with no blood components or growth factors used within 14 days before treatment
- Left ventricular ejection fraction (LVEF) of at least 50% within 28 days before treatment
- Use of reliable contraception for males and females of childbearing potential from consent until specified periods after last drug administration
- Negative pregnancy test within 7 days before treatment start for women of childbearing potential and not breastfeeding
You will not qualify if you...
- Untreated or active central nervous system metastasis or meningeal metastasis
- History of antibody drug conjugate treatment with topoisomerase I inhibitors or Her-2 targeted tyrosine kinase inhibitors (for Part A)
- Radiotherapy within 14 days prior to treatment or systemic anti-tumor therapy within 4 weeks prior
- Toxicity or complications from previous treatments not resolved to acceptable levels
- History or suspicion of interstitial lung disease or other severe lung diseases affecting respiratory function within 3 months
- Inability to swallow oral medications or disorders affecting drug absorption within 28 days prior
- Moderate to severe ascites, pleural effusion, or pericardial effusion
- Intestinal obstruction within 6 months prior or signs of obstruction unless surgically resolved
- Clinically significant cardiovascular disease
- Other cancers within 5 years except certain fully treated conditions
- Serious infections or recent intravenous antibiotic treatment
- Active hepatitis B or C infection, active tuberculosis, or known immunodeficiency
- Recent major surgery or non-healing wounds
- Allergies to study drugs or history of severe allergic reactions to similar drugs
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Uncontrolled mental illness or substance abuse
- Any other conditions judged by researchers to affect eligibility
- For Part B1: grade >1 peripheral neuropathy
- For BP102 combination therapy: bleeding or clotting disorders, poorly controlled hypertension, or severe cerebrovascular disease within 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
2
Peking University Cancer Hospital & Institute-Department of Gastrointestinal Oncology
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
4
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China, 530021
Actively Recruiting
5
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
6
Harbin Medical University Cancer Hospital-The Eighth Department of Internal Medicine
Harbin, Heilongjiang, China
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
Zhengzhou, Henan, China, 450052
Actively Recruiting
9
Hubei Cancer Hospital-Department of Abdominal Oncology
Wuhan, Hubei, China, 430079
Actively Recruiting
10
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
11
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
12
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330200
Actively Recruiting
13
Shanxi Provincial Cancer Hospital-Gastroenterology Department
Taiyuan, Shanxi, China, 030013
Actively Recruiting
14
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
15
Tianjin Medical University Cancer Institute and Hospital-Department of digestive oncology
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Z
Zhengjin Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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