Advanced Cancers
Conditions
Brief summary
TQB3107 is an target inhibitor that binds to target to induce apoptosis and inhibits the proliferation of a variety of tumor cells. This is a clinical study to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).
Interventions
DRUGTQB3107 Tablets
TQB3107 Tablets is a selective target inhibitor.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months； * Advanced malignant tumor； * The major organs are functioning well； * Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends; * Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance.
Exclusion criteria
* Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma; * Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose; * Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study； * Those with a history of drug addiction or substance abuse； * According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | 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. |
| Maximum tolerated dose (MTD) | 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. |
| Phase II Recommended Dose (RP2D) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elimination half-life (t1/2) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | The time it takes for the concentration of the drug in the plasma to be reduced by 50%. |
| Time to Peak (Tmax) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | The time it takes to reach peak concentrations after administration. |
| Peak Concentration (Cmax) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | Maximum plasma concentration of drug. |
| Area under the plasma concentration-time curve (AUC0-last) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | The area enclosed by the plasma concentration curve against the timeline. |
| Steady-state peak concentration (Css-max) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | The highest plasma drug concentration that occurs after stabilization. |
| Steady-state trough concentration (Css-min) | Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours. | Minimum plasma drug concentration during dosing. |
| Objective Response Rate (ORR) | UP to 3 years | The percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. |
| Disease Control Rate (DCR) | UP to 3 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). |
| Duration of Response (DOR) | UP to 3 years | The time from first documented response to documented disease progression. |
| Progression-free survival (PFS) | UP to 3 years | The time from the start of treatment to tumor progression or death from any cause, whichever occurs first. |
| Overall Survival (OS) | UP to 3 years | The time from the start of treatment to death from any cause. |
Countries
China
Contacts
CONTACTZhiMing Li, Doctor
CONTACTHuiLai Zhang, Doctor
Outcome results
None listed