Clinical trial NCT06413953: A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
Official title: A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancers
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Maximum tolerated dose (MTD)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Phase II Recommended Dose (RP2D)
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Elimination half-life (t1/2)
timeFrame: 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
measure: Time to Peak (Tmax)
timeFrame: 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
measure: Peak Concentration (Cmax)
timeFrame: 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
measure: Area under the plasma concentration-time curve (AUC0-last)
timeFrame: 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
measure: Steady-state peak concentration (Css-max)
timeFrame: 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
measure: Steady-state trough concentration (Css-min)
timeFrame: 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
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Cen
state: Guangdong
Study officials:
References: