A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Advanced Cancers Clinical Trial

Official title:

A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413953
• Other study ID #: TQB3107-I-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: ZhiMing Li, Doctor
• Phone: 13719189172
• Email: lzmsysu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years = age= 75 years (calculated from the date of signing the informed consent); Score 0~1 point, estimated survival = 3 months;

• Malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy;

• 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;

• Based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded.

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

Intervention

Drug:
• TQB3107 Tablets
TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Cen	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	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.	At the end of Cycle 1 (each cycle is 28 days)
Primary	Maximum tolerated dose (MTD)	MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.	At the end of Cycle 1 (each cycle is 28 days)
Primary	Phase II Recommended Dose (RP2D)	The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug.	Baseline up to 24 months
Secondary	Elimination half-life (t1/2)	The time it takes for the concentration of the drug in the plasma to be reduced by 50%.	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
Secondary	Time to Peak (Tmax)	The time it takes to reach peak concentrations after administration.	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
Secondary	Peak Concentration (Cmax)	Maximum plasma concentration of drug.	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
Secondary	Area under the plasma concentration-time curve (AUC0-last)	The area enclosed by the plasma concentration curve against the timeline.	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
Secondary	Steady-state peak concentration (Css-max)	The highest plasma drug concentration that occurs after stabilization.	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
Secondary	Steady-state trough concentration (Css-min)	Minimum plasma drug concentration during dosing.	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
Secondary	Objective Response Rate (ORR)	The percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.	Up to 2 years
Secondary	Disease Control Rate (DCR)	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).	Up to 2 years
Secondary	Duration of Response (DOR)	The time from first documented response to documented disease progression.	Up to 2 years
Secondary	Progression-free survival (PFS)	The time from the start of treatment to tumor progression or death from any cause, whichever occurs first.	Up to 2 years
Secondary	Overall Survival (OS)	The time from the start of treatment to death from any cause.	Up to 2 years