Actively Recruiting
A Study of AL58805 in Patients With Advanced Tumors
Led by Advenchen Laboratories Nanjing Ltd. · Updated on 2025-09-17
40
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I clinical trial is a dose-escalation, multicenter study in patients with advanced solid tumors. It includes tolerance studies of sequential multiple oral doses of AL58805 and pharmacokinetic studies of single and multiple doses, analyzing the tolerance range of multiple doses, observing the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in solid tumor patients, and assessing the reversibility of toxicity and the relationship between toxicity and dose.
CONDITIONS
Official Title
A Study of AL58805 in Patients With Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed advanced tumors who have no effective standard treatment or have failed previous treatments
- Completed cytotoxic chemotherapy at least 4 weeks before enrollment and recovered from toxicities to Grade 1 or less (except alopecia)
- Must have measurable tumors based on RECIST 1.1 criteria
- Adequate major organ function including neutrophil count, platelets, hemoglobin, bilirubin, creatinine, liver enzymes, and heart function
- At least 18 years old with ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- No gastrointestinal problems affecting drug absorption
- Women of childbearing potential must have a negative pregnancy test before treatment, use contraception during treatment and for 3 months after, and must not be breastfeeding
- Male participants must be surgically sterilized or use contraception during treatment and for 3 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergy to AL58805 or similar drugs
- Use of unapproved or investigational drugs within 30 days before enrollment
- Symptomatic brain or central nervous system metastases with uncontrolled symptoms within 8 weeks
- Uncontrolled hypertension requiring multiple medications, recent heart attack, certain arrhythmias, severe heart failure, poorly controlled diabetes, or unstable systemic disease
- Presence of significant ascites or pleural effusion, persistent diarrhea, or neurological/psychiatric disorders
- Urine protein levels above specified thresholds
- Use of anticoagulants requiring strict blood monitoring except low-dose prophylactic warfarin or aspirin
- Recent active blood clotting events within 6 months
- Previous treatment with AL58805
- Active hepatitis B, hepatitis C, HIV infection, immunodeficiencies, or prior organ transplant
- Concurrent other anti-tumor treatments or any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
L
Li Sha Qi
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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