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

NCT06943677 | Recruiting Phase 1

• 1 other identifier: TQB3019-I-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Advanced Malignant Cancer

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (13)

• Tmax

  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

  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)

  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)

  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)

  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

Study Arms (1)

TQB3019 capsules

EXPERIMENTAL

Single or continuous administration, 50-600 mg each time TQB3019 capsule is taken orally once a day on an empty stomach, and each cycle is 28 days.

Drug: TQB3019 capsules

Interventions

TQB3019 capsules DRUG

TQB3019 capsule is a targeted protein degrader

TQB3019 capsules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (15)

Cancer Institute & Hospital.Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

Heze Municipal Hospital

Heze, Shandong, 27400, China

NOT YET RECRUITING

The Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266075, China

NOT YET RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646099, China

NOT YET RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

NOT YET RECRUITING

Affiliated Hospital of North sichuan Medical college

Nanchong, Sichuan, 637000, China

NOT YET RECRUITING

TianJin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Institute of Hematology ＆Blood Diseases Hospital,Chinese Academy of Medical Sciences ＆Peking Union Medical College

Tianjin, Tianjin Municipality, 301617, China

NOT YET RECRUITING

Central Study Contacts

Zengjun Li, Doctor

CONTACT

+86-13642138692; zengjunli@163.com

Yvping Sun, Doctor

CONTACT

+86-13370582181; 13370582181@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: April 15, 2025
• First Posted: April 24, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-11

Locations

CN (15)