AL58805 treatment for people with advanced solid tumors.
Official title: Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors
Run by Advenchen Laboratories, LLC · NCT07179081 · Data updated 2026-11-12
This Phase I dose-escalation trial will test different oral doses of AL58805 in people with advanced solid tumors who have exhausted standard treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Advenchen Laboratories, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | December 20, 2020 |
| Main results expected | January 26, 2026 |
| Study ends | January 26, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07179081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically or cytologically confirmed advanced solid tumors who lack effective standard treatments, have measurable lesions by RECIST 1.1, and meet the specified organ function and blood-count requirements are ideal candidates.
✕Probably not a fit
Patients with poor organ function, insufficient blood counts, non-measurable disease, or very rapidly progressing illness may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter Phase I dose-escalation study of oral AL58805 in patients with advanced solid tumors. Participants will receive single and sequential multiple oral doses while investigators monitor tolerability, pharmacokinetics, and dose-limiting toxicities to define a maximum tolerated dose. The trial requires measurable disease by RECIST 1.1 and baseline organ function and blood-count criteria. Safety, reversibility of toxicity, and the relationship between dose and adverse effects are primary endpoints.
Why it matters
Potential benefit: If successful, the trial could identify a safe dosing range and schedule for AL58805 that might allow further testing for tumor control in patients without other options.
How similar studies have gone: Early-phase dose-escalation studies of similar oral oncology agents have sometimes established tolerable doses and shown occasional tumor responses, but AL58805 itself appears to be an early-stage and largely untested therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all the following criteria to be eligible: 1. Patients with histologically or cytologically confirmed advanced tumors (including but not limited to lymphoma, colorectal cancer, breast cancer, pancreatic cancer, lung cancer, head and neck cancer, bladder cancer, cholangiocarcinoma) who lack effective standard treatment options or have failed conventional standard treatments (due to disease progression or intolerable toxicity). 2. Previous treatment with cytotoxic chemotherapy, with at least 4 weeks between the end of chemotherapy and enrollment, and recovery from previous chemotherapy toxicities to ≤ Grade 1 (except alopecia). 3. Must have measurable lesions according to RECIST 1.1 criteria. 4. Major organ function: Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L (1500/mm3), platelets ≥75 × 10\^9/L, hemoglobin ≥9g/dL. Serum total bilirubin ≤2 × upper limit of normal (ULN). Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min. For patients without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal. 5. Age ≥18 years; ECOG performance status (PS) 0 or 1. 6. Expected survival time of at least 12 weeks. 7. No malabsorption or other gastrointestinal diseases affecting drug absorption. 8. For women of childbearing potential: Negative pregnancy test before treatment and use of medically approved contraception during treatment and for 3 months after treatment ends. Must be non-lactating. 9. For male subjects: Surgical sterilization or use of medically approved contraception during treatment and for 3 months after treatment ends. Ability to understand and sign informed consent. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded: 1. Known allergy to the investigational drug or drugs with similar chemical structures. 2. Use of unapproved drugs or other investigational drugs within 30 days before enrollment. 3. Status of the organ systems: Current symptomatic brain metastases or leptomeningeal metastases, or central nervous system (CNS) metastases with uncontrolled symptoms within 8 weeks of first dose. Uncontrolled hypertension requiring multiple medications (Grade 2 or higher). Acute myocardial infarction within 6 months. Current arrhythmias (e.g., long QT syndrome, Bazett's corrected QTc ≥480 ms). NYHA Class III or IV heart failure. Poorly controlled diabetes. Any unstable systemic disease (including active infection, angina, hepatic, renal, or metabolic diseases). Presence of ascites or pleural effusion (CTCAE 5.0 ≥ Grade 2). Persistent diarrhea (average watery stools ≥1 per day). History of definite neurological or psychiatric disorders (e.g., epilepsy, dementia, mood disorders). 4. The functional level of each organ: Urine protein ≥++ and 24-hour urine protein \>1.0 g. Patients treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs, should have an international normalized ratio (INR) of prothrombin time ≤1.5. In this case, low-dose warfarin (1mg, orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) can be used for prophylactic purposes. All other conditions are considered exclusion criteria. Patients with active/venous thrombosis events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism. 5. Previous treatment with the investigational drug. 6. Patients exhibiting hepatitis B surface antigen (HBsAg) positivity with HBV DNA concentrations ≥10⁴ copies/mL (equivalent to 2000 IU/mL) must initiate antiviral therapy prior to study consideration. Eligibility for enrollment is contingent upon achieving sustained HBV-DNA suppression below these threshold values. Antiviral therapy will be maintained throughout the study period with concurrent monitoring of hepatic function parameters and quantitative HBV DNA levels. The exclusion criteria further encompass individuals with detectable HCV antibodies or HCV RNA, HIV seropositivity, congenital/acquired immunodeficiencies, or prior organ transplantation history. 7. Concurrent other anti-tumor treatments. Other conditions deemed unsuitable by the investigator.
Where it's running
-
Hunan Cancer Hospital
Changsha, Hunan, China Recruiting
Study contacts
- Principal investigator: Dongfang Li — Hunan Cancer Hospital
- Study coordinator: Li Sha Qi
- Email: qilisha@advenchen.com.cn
- Phone: 025-52896159
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
GW01-200 tablets in people with advanced cancers
This early-phase study tests GW01-200 tablets in adults with advanced solid tumors or blood cancers to see if they are safe and how they behave in the body.
-
SIBP-A10 injection for adults with advanced malignant tumors
This trial will test whether SIBP-A10 injections are safe and tolerable and to identify the best dose for adults with advanced metastatic tumors.
-
Testing MDX2004 at increasing doses in adults with advanced tumors
This will test whether different doses of the experimental drug MDX2004 are safe and can shrink tumors in adults with advanced or metastatic cancer.
-
Personalized neoantigen vaccine combined with radiotherapy for advanced tumors
This study is testing a personalized vaccine made from a patient's own tumor cells combined with radiotherapy to see if it can help people with advanced tumors that haven't responded to standard treatments.
-
Evaluating CS23546 for patients with advanced tumors
This study is testing a new treatment called CS23546 to see if it's safe and how well it works for people with advanced tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.