A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets

NCT ID: NCT06507891

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2024-06-04

Brief Summary

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules in patients with non-small cell lung cancer.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQ-A3334 tablets

TQ-A3334 tablets administered orally on day 1, 8, 15 in 21-day cycle.

Group Type: EXPERIMENTAL

TQ-A3334 tablets

Intervention Type: DRUG

TQ-A3334 is a highly efficient and highly selective Toll-like receptor-7 (TLR-7) agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including interferon alpha (IFN-α), Interleukin 12 (IL-12), Tumor Necrosis Factor Alpha (TNF-α), and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.

TQ-A3334 tablets + Anlotinib capsules

TQ-A3334 tablets administered orally on day1, 8, 15 in 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Group Type: EXPERIMENTAL

TQ-A3334 tablets + Anlotinib capsules

Intervention Type: DRUG

TQ-A3334 is a highly efficient and highly selective TLR-7 agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including IFN-α (interferon-α), IL-12 (Interleukin 12), TNF-α, and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Interventions

TQ-A3334 tablets

TQ-A3334 is a highly efficient and highly selective Toll-like receptor-7 (TLR-7) agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including interferon alpha (IFN-α), Interleukin 12 (IL-12), Tumor Necrosis Factor Alpha (TNF-α), and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.

Intervention Type: DRUG

TQ-A3334 tablets + Anlotinib capsules

TQ-A3334 is a highly efficient and highly selective TLR-7 agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including IFN-α (interferon-α), IL-12 (Interleukin 12), TNF-α, and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Understood and signed an informed consent form;
• 18 years old and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; life expectancy ≥12 weeks;
• Histologically confirmed advanced non-small cell lung cancer;
• Has received at least two systemic chemotherapy regimens which is failure or intolerance；
• At least one measurable lesion（ based on Response evaluation criteria in solid tumors (RECIST) 1.1;
• The main organs function are normally；
• Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization；
• In addition to the above criteria, the extended research phase must meet the following criteria: epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) are negative; or patients with positive test results of EGFR and ALK are resistant or intolerant after receiving the targeted drug treatment.

Exclusion Criteria

• Small cell lung cancer
• Other malignant tumors that have appeared or are presently present within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
• Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks
• Expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period
• Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
• Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first administration
• Hypersensitivity to TQ-A3334 or its excipient
• Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis
• Has unrelieved toxicity reactions ≥ grade 1 due to previous treatment
• Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear
• Has thyroid dysfunction that requires drug treatment within 6 months before the first administration
• Has multiple factors affecting oral medication
• Has any severe acute complications before the first administration
• Have participated in other clinical trials within 4 weeks before the first administration
• According to the judgement of the researchers, there are other factors that may lead to the termination of the study
• In addition to the above criteria, the extended research phase must meet the following criteria:

1. Pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis;

2. EGFR and ALK are positive untreated with relevant targeted drugs;

3. Has received anlotinib hydrochloride capsules.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jingling Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

TQ-A3334-I-02

Identifier Type: -

Identifier Source: org_study_id