Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer

NCT05815862 | Completed Phase 2

• 1 other identifier: AL2846-II-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints.

Conditions

Advanced Lung Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Objective remission rate (ORR)

  ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD).

  From baseline up to 12 months.

• Progression free survival (PFS)

  PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

  From baseline up to 12 months.

Secondary Outcomes (8)

• Disease control rate (DCR)

  From baseline up to 12 months.

• Duration of remission (DOR)

  From baseline up to 12 months.

• Overall survival (OS)

  From baseline to the death events, assessed up to 3 years.

• Adverse events (AEs) rate

  From baseline to 28 days after the last dose or initiation of a new antineoplastic therapy (whichever comes first).

• Peak concentration (Cmax)

  Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

Study Arms (1)

AL2846 capsule

EXPERIMENTAL

orally administer AL2846 capsules monotherapy, 28 days as a treatment cycle.

Drug: AL2846 capsule

Interventions

AL2846 capsule DRUG

AL2846 is a multi-target tyrosine kinase inhibitor.

AL2846 capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with advanced lung cancer or ovarian cancer confirmed by histopathology or cytology;
• Age: 18\~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0-1;
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
• Normal function of main organs
• The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period;Male subjects should agree to use contraception during the study period and for 6 months after the study period ends;
• The patient voluntarily joined the study and signed the informed consent form, with good compliance.

You may not qualify if:

• Combined with the following diseases or medical history:
• Other malignant tumors have occurred or are present at the same time within\<3 years before the first administration.
• Inability to tolerate multiple factors affecting oral medication due to any reason;
• Common Terminology Criteria for Adverse Events (CTCAE) 5.0 \> grade 1 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss;
• Major surgical treatment or obvious traumatic injury was received within 4 weeks before the first administration;
• The presence of unhealed wounds, fractures, gastric and duodenal active ulcers, persistent positive fecal occult-blood, ulcerative colitis, or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation;
• Arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months before the first medication;
• Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders;
• Subjects with any severe and/or uncontrollable disease；
• Tumor related symptoms and treatment:
• Had received chemotherapy, radiation, or other anticancer therapy within 4 weeks prior to first dose;
• Within 2 weeks before the first dose, received Chinese Traditional drugs with anti-tumor indications specified in theNational Medical Products Administration (NMPA) approved drug instructions
• Previously treated with anti-angiogenic drugs such as Cabozantinib, Anlotinib, Endostar and Bevacizumab;
• Imaging Computed Tomography (CT)or Magnetic Resonance Imaging (MRI) shows that the tumor has invaded important blood vessels or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
• There is a history of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, severe radiation pneumonia, drug-induced lung disease, and evidence of severe active lung inflammation indicated by chest CT examination during screening;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225009, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: February 15, 2023
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)