Sun Yat-sen University Cancer Cen
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
NCT Number: NCT06413953
TQB3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. This clinical study aims to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DLT refers to toxicities that are associated with the drug and occur from the first medication administration to the end of the first treatment cycle, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: Baseline up to 24 months
The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug.
Time frame: Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
The time it takes for the concentration of the drug in the plasma to be reduced by 50%.
Time frame: Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose;Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
The time it takes to reach peak concentrations after administration.
Time frame: Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
Maximum plasma concentration of drug.
Time frame: Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
The area enclosed by the plasma concentration curve against the timeline.
Time frame: Day 1 of cycle 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
The highest plasma drug concentration that occurs after stabilization.
Time frame: Day 1 of cycles 0 and 2: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; Days 1, 8 and 15 of cycle 1: in 30 minutes (pre-dose); Day 26 of cycle 1: in 30 minutes (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
Minimum plasma drug concentration during dosing.
Time frame: Up to 2 years
The percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: Up to 2 years
Proportion of patients whose tumors achieve remission (PR+CR) and stable disease (SD) after treatment and can maintain the minimum timeframe required according to accepted response evaluation criteria (e.g., RECIST version 1.1 for solid tumors).
Time frame: Up to 2 years
The time from first documented response to documented disease progression.
Time frame: Up to 2 years
The time from the start of treatment to tumor progression or death from any cause, whichever occurs first.
Time frame: Up to 2 years
The time from the start of treatment to death from any cause.
Contact information is provided by the study sponsor or research team.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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