A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsules in Subjects With Advanced Malignant Tumors

The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3019 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3019 capsules.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Cancer
• Intervention / Treatment: Drug: TQB3019 capsules

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zengjun Li, Doctor; Phone Number: +86-13642138692; Email: zengjunli@163.com
• Study Contact Backup: Name: Yvping Sun, Doctor; Phone Number: +86-13370582181; Email: 13370582181@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Institute & Hospital.Chinese Academy of Medical Sciences
      • Contact: Peng Liu, Doctor; Phone Number: +86 13910216310; Email: 13910216310@163.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital of Southern Medical University
      • Contact: Xutao Guo, Doctor; Phone Number: +86 13802426709; Email: Gxt827@126.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
      • Contact: Keshu Zhou, Doctor; Phone Number: 13674902391; Email: drzhouks77@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Lei Fan, Doctor; Phone Number: +86 13813976136; Email: fanlei3014@126.com
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Fei Li, Doctor; Phone Number: +86 13970038386; Email: lifeigcp2022@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Contact: Pengcheng He, Doctor; Phone Number: 18991232609; Email: Hepc_gcp@163.com
  • Shandong
    • Heze, Shandong, China, 27400
      • Recruiting
      • Heze Municipal Hospital
      • Contact: Yuqi Sang, Doctor; Phone Number: +86 19953030611; Email: sangyuqi1966@163.com
    • Jinan, Shandong, China, 250117
      • Recruiting
      • The Cancer Hospital Affiliated to Shandong First Medical University
      • Contact: Zengjun Li, Doctor; Phone Number: +86-13642138692; Email: zengjunli@163.com
    • Qingdao, Shandong, China, 266075
      • Recruiting
      • The Affiliated Hospital Of Qingdao University
      • Contact: Xia Zhao, Doctor; Phone Number: +86 18661803088; Email: alice-xia@163.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200065
      • Recruiting
      • Tongji Hospital of Tongji University
      • Contact: Jianfei Fu, Doctor; Phone Number: +86 18621909612; Email: fjf2017@tongji.edu.cn
  • Sichuan
    • Luzhou, Sichuan, China, 646099
      • Recruiting
      • The Affiliated Hospital of Southwest Medical University
      • Contact: Xiaoming Li, Doctor; Phone Number: +86 13700986866; Email: LXM6358@21.com.cn
    • Mianyang, Sichuan, China, 621000
      • Recruiting
      • Mianyang Central Hospital
      • Contact: Yu Zhang, Doctor; Phone Number: 15228700888; Email: 543703371@qq.com
    • Nanchong, Sichuan, China, 637000
      • Recruiting
      • Affiliated Hospital of North Sichuan Medical College
      • Contact: Guobo Du, Master; Phone Number: +86 13890800046; Email: duguobo@yeah.net
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Recruiting
      • Tianjin Medical University Cancer Institute＆Hospital
      • Contact: Lihua Qiu, Doctor; Phone Number: +86 18722221227; Email: JZXQLH@163.com
    • Tianjin, Tianjin Municipality, China, 301617
      • Recruiting
      • Institute of Hematology ＆Blood Diseases Hospital,Chinese Academy of Medical Sciences ＆Peking Union Medical College
      • Contact: Mingyuan Sun, Master; Phone Number: 022-23608390; Email: sunmingyuan@ihcama.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
• ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
• Clearly diagnosed recurrent / refractory hematological tumors that meet the World Health Organization (WHO) definition;
• At least 1 measurable lesion for efficacy evaluation.
• The function of main organs is normal.
• Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.

Exclusion Criteria:

• Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
• Subjects with central nervous system aggression (CNS);
• Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
• Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
• Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
• Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
• The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
• Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
• Subjects had an arteriovenous thrombosis event within 6 months.
• Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
• Subjects with any severe and/or uncontrolled disease.
• Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
• Previously received treatment with drugs similar to TQB3019 capsules;
• Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment)
• Study treatment related: subjects received live or messenger RNA (mRNA) vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
• Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
• According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB3019 capsules; Single or continuous administration, depending on different groups, 25-600 mg of TQB3019 capsules are taken orally on an empty stomach or after a meal, once a day, and each cycle is 28 days.	Drug: TQB3019 capsules; TQB3019 capsule is a targeted protein degrader

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.	At the end of Cycle 1 (Each cycle is 28 days)
Maximum tolerated dose (MTD)	MTD was 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)
Recommended Phase II Dose (RP2D)	DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3019 capsules in adult patients with Advanced Malignant Cancer.	Baseline up to 24 months
Maximum assessed dose (MAD)	Recommendations made by the investigator and sponsor based on clinical safety, efficacy, pharmacokinetic, and pharmacodynamic data will be considered the highest dose level to complete dose exploration in the absence of an MTD	Baseline up to 24 months
Adverse events (AEs)	The occurrence of all adverse events (AEs)	From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years)
Serious adverse events (SAEs)	The occurrence of all serious adverse events (SAEs) .	From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years)
Abnormal incidence of laboratory test indicators	Incidence and severity of abnormal laboratory values	From the time the subject receives TQB3019 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years)
Overall response rate (ORR)	The proportion of subjects with best response of Complete Response (CR), Partial Response (PR), Partial Response with Lymphocytosis (PR-L), Very Good Partial Response (VGPR), and Minimal Response (MR).	From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to Reach the Maximum Plasma Concentration.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle 1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Cmax	Cmax is the maximum plasma concentration of TQB3019.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Elimination half-life (t1/2)	To evaluate the Elimination half-life (t1/2) after oral dose of TQB3019 capsules to subjects.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)	To characterize the pharmacokinetics of TQB3019 by assessment of area under the plasma concentration time curve from the first dose to a certain time.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Apparent clearance (CL/F)	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body..	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Apparent volume of distribution (Vd/F)	Apparent volume of distribution of the TQB3019 in plasma.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Minimum concentration (Cmin)	Minimum observed concentration (Cmin) of TQB3019	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Complete Remission Rate (CRR)	The proportion of tumors that have a complete response after treatment.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Disease Control Rate (DCR)	The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a cancer treatment in clinical trials.	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Duration of Response (DOR)	The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks
Progression Free Survival (PFS)	The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Overall Survival (OS)	the time from start of study treatment to date of death due to any cause	Single Day1/First dose: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 hours post dose Cycle1 Day 8, 15, 28: pre-dose; 0.5, 1, 2, 4, 6, 8, 12, 24 hours at days 28 post dose, each cycle is 28 days
Bruton's tyrosine kinase (BTK) protein levels	BTK protein levels in peripheral blood mononuclear cells (PMBCs)	First dose: pre-dose, 4, 24 hours post-dose; cycle 1 day 8 pre-dose, day 28 pre-dose and 4 hours post-dose; cycle 2 day 14, 28 pre-dose; cycle 3-10 day 28 pre-dose; from cycle 11, every even cycle day 28 pre-dose; Progressive Disease or End of Treatment.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB3019-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No