Status unknownNCT04273815Updated Jul 8, 2020

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

A Phase 1/2 interventional study of TQ-A3334 and Anlotinib in Non-small Cell Lung Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Non-small Cell Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

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Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

1.Understood and signed an informed consent form; 2. 18 years old and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; life expectancy ≥12 weeks; 3.Histologically confirmed advanced non-small cell lung cancer; 4. Has received at least two systemic chemotherapy regimens which is failure or intolerance; 5. At least one measurable lesion（ based on RECIST1.1）; 6. The main organs function are normally; 7. 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; 8. In addition to the above criteria, the extended research phase must meet the following criteria: EGFR and 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

Exclusion Criteria:

1. Small cell lung cancer; 2. Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer; 3. 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; 4. Expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period; 5. 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; 6. Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first administration; 7. Hypersensitivity to TQB3804 or its excipient; 8. Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis; 9. Has unrelieved toxicity reactions ≥ grade 1 due to previous treatment; 10. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear; 11. Has thyroid dysfunction that requires drug treatment within 6 months before the first administration; 12. Has multiple factors affecting oral medication; 13.Has any severe acute complications before the first administration; 14. Have participated in other clinical trials within 4 weeks before the first administration; 15. According to the judgement of the researchers, there are other factors that may lead to the termination of the study; 16. 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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
TQ-A3334 tablets
TQ-A3334 tablets administered orally on day1, 8, 15 in 21-day cycle.
Drug: TQ-A3334
Experimental
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).
Drug: TQ-A3334 · Drug: Anlotinib

Interventions

DrugTQ-A3334
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.
DrugAnlotinib
Anlotinib is a multi-target receptor tyrosine kinase inhibitor.

What researchers measure

Primary outcomes

Adverse events (AE)
The occurrence of adverse events and serious adverse events.
Time frame: Baseline up to 21 days
Dose limited toxicity (DLT) and Maximum tolerable dose (MTD)
DLT defined as any of the following events occurring during the study related to drugs ：（1） ≥grade 3 non-hematologic toxicity; （2）Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; （3）Grade 3 neutropenia with fever confirmed at least 2 times within 2 days; （4）Immune-related interstitial pneumonia ≥ grade 2 ；. （5）Decreased ventricular ejection fraction ≥ grade 2 ；（6）Retinal vein occlusion (RVO), uveitis ≥ grade 2 ; MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
Time frame: Baseline up to 21 days

Secondary outcomes

Tmax
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
Time frame: 5minutes, 15minutes, 0.5hour, 45minutes, 1hour, 1.5hour, 4hour, 12hour, 24hour, 48hour, 96hour, 144hour after oral administration on day 1 and day 29; 30min before oral administration on day 1, day8, day15,day22 and day 29.
Cmax
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Time frame: 5minutes, 15minutes, 0.5hour, 45minutes, 1hour, 1.5hour, 4hour, 12hour, 24hour, 48hour, 96hour, 144hour after oral administration on day 1 and day 29; 30min before oral administration on day 1, day8, day15,day22 and day 29.
t1/2
t1/2 is time it takes for the blood concentration of TQ-A3334 or metabolite(s) to drop by half.
Time frame: 5minutes, 15minutes, 0.5hour, 45minutes, 1hour, 1.5hour, 4hour, 12hour, 24hour, 48hour, 96hour, 144hour after oral administration on day 1 and day 29; 30min before oral administration on day 1, day8, day15,day22 and day 29.
AUC0-t
To characterize the pharmacokinetics of TQ-A3334 by assessment of area under the plasma concentration time curve from zero to infinity.
Time frame: 5minutes, 15minutes, 0.5hour, 45minutes, 1hour, 1.5hour, 4hour, 12hour, 24hour, 48hour, 96hour, 144hour after oral administration on day 1 and day 29; 30min before oral administration on day 1, day8, day15,day22 and day 29.
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Time frame: up to 96 weeks
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 96 weeks
Duration of Response (DOR)
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause.
Time frame: up to 96 weeks
Disease control rate（DCR）
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 96 weeks

Study locations

1 of 1 sites recruiting

Jinling Hospital
Nanjing, Jiangsu 210023, China
- Yong Song, Doctor · Contact · yong_song6310@yahoo.com
- Yong Song, Doctor · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04273815
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party: Sponsor
First posted: Feb 18, 2020
Start date: Jul 6, 2020
Primary completion: Jan 31, 2021 (estimated)
Completion: Jan 31, 2021 (estimated)
Last update: Jul 8, 2020

Study contacts

Yong Song, Doctor

Contact

yong_song6310@yahoo.com

025-80860148

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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