A Phase 1 interventional study of TQB3006 tablets in Advanced Malignant Neoplasm, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →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.
Exclusion Criteria:
Tumor-related symptoms and treatment:
TQB3006 tables is administered as a single dose or multiple dose .Take200-1200 mg per day; Take TQB3006 orally on an empty stomach once or twice a day, 21 days as a cycle.
Drug: TQB3006 tablets
TQB3006 is an inhibitor protein.
Dose limiting toxicity (DLT)
DLT will be defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version5.0), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.
Time frame: At the end of Cycle 1 (21 Days).
Maximum tolerated dose (MTD)
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: At the end of Cycle 1 (21 Days).
Recommended phase II dose (RP2D)
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3006 tablets in adult patients with Advanced Malignant Cancer
Time frame: Baseline up to 24 months.
Adverse events (AE)
The occurrence of all adverse events (AE).
Time frame: 30 days after the last dose.
Serious adverse events (SAE)
The occurrence of all serious adverse events (SAE).
Time frame: 30 days after the last dose.
Time to reach maximum plasma concentration (Tmax)
To characterize the pharmacokinetics of TQB3006 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Peak concentration (Cmax)
The maximum observed plasma concentration of study drug. Each cycle is 21 days.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Area under the concentration-time curve (AUC [0-infinity])
Area under the concentration-time curve from zero to infinity
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Area under the concentration-time curve (AUC [0-t])
Area under the concentration-time curve from the first dose to a certain time point.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Apparent clearance (CL/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution of the TQB3006 in plasma.
Time frame: Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Objective response rate (ORR)
Defined as the percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.