A Study of AL8326 in Non-Small Cell Lung Cancer

NCT06794957 | Active Not Recruiting Phase 1

• 1 other identifier: AL8326-CN-008
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 10

Brief Summary

This trial is a multicenter, single arm, open, phase IB clinical trial, designed to evaluate the preliminary efficacy and safety of AL8326 in patients with non-small cell lung cancer (NSCLC) who relapsed or progressed after multi line treatment and failed standard treatment.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  The proportion of subjects achieving complete remission (CR) and partial remission (PR) with optimal efficacy according to RECIST 1.1.

  Every 2 cycles,up to 24 months (each cycle is 28 days)

Secondary Outcomes (6)

• Duration of remission (DOR)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• Disease Control Rate (DCR)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• Duration of Disease Control (DDC)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• Progression Free Survival (PFS)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• Overall Survival (OS)

  Cycle 1 Day 1 up to 24 months(each cycle is 28 days)

Study Arms (1)

AL8326

EXPERIMENTAL

Subject will received AL8326 once daily for 28-days cycle until intolerable toxicity or disease progression or death or voluntary withdrawal the end of this study. Subjects will be evaluated for anti-tumor efficacy and corresponding safety examinations every 2 cycles, and tumor disease status will be according to Response Evaluation Criteria in Solid Tumours（RECIST 1.1）.

Drug: AL8326 tablets

Interventions

AL8326 tablets DRUG

10mg/tablet;Oral administration, once daily.

Also known as: AL8326

AL8326

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to understand and be willing to sign a written informed consent form before beginning any study-related procedures;
• Age ≥18 years, both male and female;
• Patients with advanced non-small cell lung cancer who failed standard treatment confirmed by pathology (disease progression after treatment or intolerable toxic and side effects of treatment) or did not have standard treatment (group A: Patients with non-small cell lung cancer without brain metastasis confirmed by imaging at baseline; group B: Patients with non-small cell lung cancer with brain metastasis confirmed by imaging at baseline)；
• Have received at least two or more systemic treatment regimens;
• Have at least one measurable tumor lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1);
• Have received prior chemotherapy with a cytotoxic agent, with an interval of at least 4 weeks between the end of chemotherapy and the time of enrollment, and have recovered to grade ≤1 (except alopecia areata) from a toxic reaction to prior chemotherapy
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Oncology Group（ECOG） score of 0 -1.
• Subjects have adequate organ and bone marrow function and meet the following laboratory test criteria:
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 /L (1500/mm\^3), platelets ≥ 80 x 10\^9/L;cifang
• Hemoglobin ≥ 9.0 g/dl;
• Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia manifesting as elevated unconjugated bilirubin in the absence of evidence of hemolysis or hepatic pathology); and for those without liver transfer, alanine aminotransferase ( ALT ）and aspartate aminotransferase (AST) ≤ 2.5 × ULN for those without liver metastases, and ALT and AST ≤ 5 × ULN for those with liver metastases;
• Renal function: serum creatinine ≤1.5×ULN and standardized endogenous creatinine clearance ≥60 ml/min estimated by the Cockcroft-Gault formula, Ccr(ml/min)=\[(140-age)×body weight(kg)\]/\[72×Scr(mg/dl)\], and for females, it is calculated as follows×0.85;
• Coagulation function: International Normalized Ratio (INR) ≤1.5;
• Screening period left ventricular ejection fraction (LVEF) \> 50%.

You may not qualify if:

• The patient used AL8326 tablets.
• Allergic to AL8326 or its analogues, or to any component in the prescription of AL8326;
• The last dose of systemic cytotoxic or investigational therapy was administered within 28 days prior to initiation of study treatment. Or the last dose of a non-cytotoxic, non-investigational treatment (i.e., radiation therapy, hormone therapy, targeted therapy, immunotherapy, etc.) was administered within 14 days prior to initiation of study treatment;
• Major surgery (defined as requiring general anesthesia within 28 days prior to initiation of study treatment or general anesthesia for minor surgical procedures within 7 days prior to initiation of study treatment).
• Pregnant or lactating female patients.
• History of a prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of the safety or efficacy of the investigational therapeutic agents.
• Patients with active or untreated central nervous system（CNS） metastases; subjects with stabilized brain metastases will need to meet the following criteria for enrollment: a) no imaging-proven progression ≥4 weeks after completion of treatment; b) completion of treatment within ≥28 days prior to the first dose of the test drug; and c) no need to be treated with systemic corticosteroids (\>10 mg/day of prednisone or equivalent dose) ≤28 days prior to the first dose of the test drug.
• Peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal disease with risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to starting study treatment.
• The patients have had an arterial/venous thrombotic event such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months prior to screening;
• Presence of uncontrolled infection (within 2 weeks prior to administration of test drug).
• New York Heart Association (NYHA) class III or IV congestive heart failure as achieved by cardiac function.
• Had the following history of heart disease within 6 months before starting study treatment:
• Cardiac angioplasty or stenting, or
• Myocardial infarction, or
• Unstable angina, or

Sponsors & Collaborators

• Advenchen Laboratories, LLC: lead

Study Sites (10)

The First Affiliated Hospital of Bengbu Medicaal University

Bengbu, Anhui, 233004, China

Location

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

Location

Xuancheng People´s Hospital

Xuancheng, Anhui, 242099, China

Location

Anyang Cancer Hospital

Anyang, Henan, 455100, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450052, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Nanjing Chest Hospital

Nanjing, Jiangsu, 210029, China

Location

Sir Run Run Shaw Hospital (SRRSH),affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

The First Hospital Of Jiaxing

Jiaxing, Zhejiang, 314001, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xingya Li

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: January 27, 2025
• Study Start: May 19, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2024-02

Locations

CN (10)