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A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.
Led by Advenchen Laboratories, LLC · Updated on 2026-02-06
228
Participants Needed
15
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors
CONDITIONS
Official Title
A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Age 18 years or older
- Histologically confirmed advanced recurrent or metastatic solid tumors
- Failure of standard therapy, no effective treatment available, or receiving Toripalimab as second-line or later treatment
- At least one measurable lesion by RECIST 1.1
- Completed prior cytotoxic chemotherapy at least 4 weeks before enrollment and recovered from toxicities to Grade 1 or less
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ function including bone marrow, renal, hepatic, and coagulation parameters
- Left ventricular ejection fraction greater than 50%
- Systolic blood pressure less than 140 mmHg and diastolic less than 90 mmHg
- Women of childbearing potential must have negative pregnancy test and use effective contraception; non-lactating
- Ability and willingness to comply with study protocol and follow-up
You will not qualify if you...
- Received systemic cytotoxic or investigational therapy within 28 days, or non-cytotoxic therapy within 14 days prior to study treatment
- Major surgery within 28 days or minor surgery within 7 days before treatment
- Pregnant or lactating women
- History of second primary malignancy interfering with study assessments
- Active or untreated CNS metastases; stable brain metastases allowed with conditions
- Active or suspected autoimmune disease or interstitial lung disease
- Requirement for systemic corticosteroids or immunosuppressive drugs within 14 days before treatment
- Certain gastrointestinal conditions with risk of perforation or recent related surgeries
- Untreated deep vein thrombosis within 6 months
- Uncontrolled infection
- NYHA Grade III or higher congestive heart failure
- Recent cardiac events within 6 months including angioplasty, myocardial infarction, unstable angina, or stroke
- Unhealed wounds, fractures, ulcers, or symptomatic peripheral vascular disease
- Significant bleeding or coagulation disorders within 6 months
- QTcF 470 msec or greater on screening ECG
- Significant proteinuria within 28 days prior to treatment
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History of organ transplantation
- Conditions affecting oral intake or absorption of AL8326
- Use of prohibited medications or transfusions within 14 days prior to treatment
- Known allergy or severe drug hypersensitivity
- Severe or unstable medical or psychiatric conditions jeopardizing safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
National GCP Center for Anticancer Drugs,The Independent Ethics Committee
Beijing, Beijing Municipality, China, 100021
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2
The Cancer Hospital of the Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
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3
Hunan Cancer Hospital
Hunan, Changsha, China, 410000
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4
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350001
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5
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515000
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6
Yuebei People's Hospital
Shaoguan, Guangdong, China, 51200
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7
The First Affiliated Hospital of Guilin Medical Universty
Guilin, Guangxi, China
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8
Liuzhou Workers' Hospital
Liuzhou, Guangxi, China
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9
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530000
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10
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
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11
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
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12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
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13
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710000
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14
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
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15
SIR RUN RUN SHAW Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China, 310016
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Research Team
J
Jianbo Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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