NCT06507891TerminatedPhase 1
A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country30 target enrollmentStarted: July 6, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Adverse events (AE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis;
- •EGFR and ALK are positive untreated with relevant targeted drugs;
- •Has received anlotinib hydrochloride capsules.
Arms & Interventions
TQ-A3334 tablets
Experimental
TQ-A3334 tablets administered orally on day 1, 8, 15 in 21-day cycle.
Intervention: TQ-A3334 tablets (Drug)
TQ-A3334 tablets + Anlotinib capsules
Experimental
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).
Intervention: TQ-A3334 tablets + Anlotinib capsules (Drug)
Outcomes
Primary Outcomes
Adverse events (AE)
Time Frame: Baseline up to 21 days
The occurrence of adverse events and serious adverse events.
Dose limited toxicity (DLT)
Time Frame: Baseline up to 21 days
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.
Maximum tolerable dose (MTD)
Time Frame: Baseline up to 21 days
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
Secondary Outcomes
- Progression-free survival (PFS)(Up to 96 weeks)
- Tmax(5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29)
- Cmax(5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29)
- t1/2(5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29)
- Area under the plasma concentration-time curve (AUC 0-t)(5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29)
- Overall response rate (ORR)(Up to 96 weeks)
- Duration of Response (DOR)(Up to 96 weeks)
- Disease control rate (DCR)(Up to 96 weeks)
Investigators
Study Sites (1)
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