A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

NCT06413953 | Recruiting Phase 1

• 1 other identifier: TQB3107-I-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Cancers

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (11)

• Elimination half-life (t1/2)

  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

• Time to Peak (Tmax)

  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

• Peak Concentration (Cmax)

  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

• Area under the plasma concentration-time curve (AUC0-last)

  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

• Steady-state peak concentration (Css-max)

  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

Study Arms (1)

TQB3107 tablets

EXPERIMENTAL

Dosing regimen 1 (20/28): 28 days per cycle (4 weeks), the medication is administered once daily for 5 consecutive days per week, followed by a 2-day break. The initial dose is a single fasting dose of C0, with a subsequent 7-day observation period. Dosing regimen 2 (28/28): 28 days per cycle, the medication is administered once daily for the entire 28-day period, all other dosing requirements are consistent with Regimen 1.

Drug: TQB3107 Tablets

Interventions

TQB3107 Tablets DRUG

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

TQB3107 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

ZhiMing Li, Doctor

CONTACT

13719189172; lzmsysu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: June 27, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2023-12

Locations

CN (1)