Advanced TumorsPhase 1NCT07179081

A Study of AL58805 in Patients With Advanced Tumors

A Phase 1 study testing AL58805 in people with Advanced Tumors, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Tumors
What is being tested?: AL58805
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 20 Dec 2020to 26 Jan 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all the following criteria to be eligible:
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).
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).
Must have measurable lesions according to RECIST 1.1 criteria.
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.
Age ≥18 years; ECOG performance status (PS) 0 or 1.

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Expected survival time of at least 12 weeks.
No malabsorption or other gastrointestinal diseases affecting drug absorption.
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.
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.

Who cannot join

Subjects meeting any of the following criteria will be excluded:
Known allergy to the investigational drug or drugs with similar chemical structures.
Use of unapproved drugs or other investigational drugs within 30 days before enrollment.
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).

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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).
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.
Previous treatment with the investigational drug.
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.
Concurrent other anti-tumor treatments. Other conditions deemed unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Sha Qi contact

025-52896159

qilisha@advenchen.com.cn

China1 site, 1 recruiting

Hunan Cancer Hospital
Changsha, Hunan, 410013
Hongkun Cai, 0731-89762695, hnszlyy_irb@163.com
Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors

Conditions: Advanced Tumors
Being tested: AL58805

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AL58805Drug
Oral,Multiple administrations, once or twice daily（20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID；）

Study groups in NCT07179081
Study group	Role	What they receive
AL58805	Experimental	20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID； Receives: Drug: AL58805

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicity
It is the evaluation of dose-limiting toxicity (DLT) and general safety that occur during the single administration and the first continuous administration treatment cycle. The evaluation depends on the criteria for DLT. The parameters used to assess safety in this study include adverse events, physical examinations, vital signs (especially blood pressure), and laboratory tests (including serum chemistry, hematology, urine routine, and electrocardiogram (ECG), etc.)
Measured: From signing the ICF until 28 days after the first dosing

Secondary outcomes (7)

Tmax
Determine the time to reach maximum plasma concentration (Tmax) of AL58805 after single administration and continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
Css_min
Measure the minimum steady - state plasma concentration (Css_min) of AL58805 during continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
Css_av
Calculate the average steady - state plasma concentration (Css_av) of AL58805 during continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
T1/2
Estimate the elimination half - life (T1/2) of AL58805 after single administration and continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
CL or CL/F
Assess the clearance (CL) or apparent clearance (CL/F) of AL58805 after single administration and continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
AUCss
Evaluate the area under the steady - state plasma concentration - time curve (AUCss) of AL58805 during continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
DF
Calculate the fluctuation index (DF) of AL58805 during continuous administration for 28 days.
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 202026 Jan 2026

First posted17 Sep 2025
Study start20 Dec 2020
Primary completion26 Jan 2026 (estimated)
Study completion26 Jan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07179081
Sponsor's protocol ID: AL58805-CN-001B
Status last verified: Sep 2025
First submitted: 5 Sep 2025
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors
ClinicalTrials.gov ID: NCT07179081
Acronym / sponsor ID: AL58805-CN-001B
Conditions: Advanced Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
Study start: 20 Dec 2020 (actual)
Primary completion: 26 Jan 2026 (estimated)
Study completion: 26 Jan 2026 (estimated)
First posted: 17 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AL58805	Experimental	Drug: AL5880520mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID；

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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).
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).
Must have measurable lesions according to RECIST 1.1 criteria.
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.
Age ≥18 years; ECOG performance status (PS) 0 or 1.

Key exclusion criteria (12 listed)

Known allergy to the investigational drug or drugs with similar chemical structures.
Use of unapproved drugs or other investigational drugs within 30 days before enrollment.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AL58805Oral,Multiple administrations, once or twice daily（20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID；）	Drug	AL58805

Primary outcome

Dose-limiting toxicity
Time frame: From signing the ICF until 28 days after the first dosing
It is the evaluation of dose-limiting toxicity (DLT) and general safety that occur during the single administration and the first continuous administration treatment cycle. The evaluation depends on the criteria for DLT. The parameters used to assess safety in this study include adverse events, physical examinations, vital signs (especially blood pressure), and laboratory tests (including serum chemistry, hematology, urine routine, and electrocardiogram (ECG), etc.)

7 secondary outcomes

Tmax
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
Css_min
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
Css_av
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
T1/2
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
CL or CL/F
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
AUCss
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.
DF
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Li Sha Qi contact

025-52896159

qilisha@advenchen.com.cn

Dongfang Li principal investigator

Hunan Cancer Hospital

Yongchang Zhang principal investigator

Hunan Cancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AL58805 in people with Advanced Tumors, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Sha Qi (025-52896159, qilisha@advenchen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: From signing the ICF until 28 days after the first dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07179081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.