Advanced CancersPhase 1NCT06413953
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
A Phase 1 study testing TQB3107 Tablets in people with Advanced Cancers, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- TQB3107 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 12 sitesChina
- Study dates
- 27 Jun 2024to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 11 recruiting
- Recruiting
Shandong Medical And Pharmaceutical University Hospital
Binzhou, Shandong, 256699
Na Gao, Doctor, 15966356316, gn2882155@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
YaJun Li, Doctor, 19918803330, liyajun@hnca.org.cn
- Recruiting
The First People's Hospital Of Changzhou
Changzhou, Jiangsu, 213000
WeiYing Gu, Doctor, 0519-68871093, guweiying@czfph.com
- Recruiting
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 67000
ZhiHua Zhang, Doctor, 15633142905, zzhangzhihua@163.com
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan, 610041
LiQun Zou, Doctor, 18980601027, hxlcyxy@163.com
- Recruiting
Sun Yat-sen University Cancer Cen
Guangzhou, Guangdong, 510060
ZhiMing Li, Doctor, 13719189172, lzmsysu@163.com
- Withdrawn
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
QingYuan Zhang, Doctor, 13313612989, sy86298276@163.com
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
XiaoMing Li, Doctor, 13700986866, LXM6358@21.com.cn
Qing Peng, Doctor, 15984007875, pq9712118@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Rong Tao, Doctor, 13651603660, hkutao@hotmail.com
- Recruiting
Tianjin Municipality Locations
Tianjin, Tianjin Municipality, 300060
HuiLai Zhang, Doctor, 18622221228, zhlwgq@126.com
- Recruiting
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, 519000
MingYuan Chen, Doctor, 13903052650, chmingy@mail.sysu.edu.cn
About this study
Official title: A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
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).
- Conditions
- Advanced Cancers
- Being tested
- TQB3107 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3107 TabletsDrug
TQB3107 Tablets is a selective target inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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 (12/28): every 28 days per cycle, with intermittent dosing. Receives: Drug: TQB3107 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 24 months
Secondary outcomes (11)
Elimination half-life (t1/2)
The time it takes for the concentration of the drug in the plasma to be reduced by 50%.
Measured: 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.
Time to Peak (Tmax)
The time it takes to reach peak concentrations after administration.
Measured: 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.
Peak Concentration (Cmax)
Maximum plasma concentration of drug.
Measured: 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.
Area under the plasma concentration-time curve (AUC0-last)
The area enclosed by the plasma concentration curve against the timeline.
Measured: 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.
Steady-state peak concentration (Css-max)
The highest plasma drug concentration that occurs after stabilization.
Measured: 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.
Steady-state trough concentration (Css-min)
Minimum plasma drug concentration during dosing.
Measured: 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.
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.
Measured: UP to 3 years
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).
Measured: UP to 3 years
Duration of Response (DOR)
The time from first documented response to documented disease progression.
Measured: UP to 3 years
Progression-free survival (PFS)
The time from the start of treatment to tumor progression or death from any cause, whichever occurs first.
Measured: UP to 3 years
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Measured: UP to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start27 Jun 2024
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413953
- Sponsor's protocol ID
- TQB3107-I-01
- Status last verified
- Jul 2026
- First submitted
- 8 May 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No