NCT06943677

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

Recruiting now Phase 1 Last updated 10 February 2026

What this trial tests

Phase 1 trial testing TQB3019 capsules in Advanced Malignant Cancer in 80 participants. Currently enrolling.

Timeline

26 May 2025

Primary endpoint
1 December 2027

1 December 2028

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	26 May 2025
Primary completion	1 December 2027
Estimated completion	1 December 2028
Sites	15 locations across China

Drugs / interventions tested

• TQB3019 capsules — full drug profile →

Conditions studied

• Advanced Malignant Cancer — all drugs for Advanced Malignant Cancer →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced Malignant Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose Limiting Toxicity (DLT)
  Time frame: At the end of Cycle 1 (Each cycle is 28 days)
  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.
• Maximum tolerated dose (MTD)
  Time frame: At the end of Cycle 1 (Each cycle is 28 days)
  MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
• Recommended Phase II Dose (RP2D)
  Time frame: Baseline up to 24 months
  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.
• Maximum assessed dose (MAD)
  Time frame: Baseline up to 24 months
  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
• Adverse events (AEs)
  Time frame: 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)
  The occurrence of all adverse events (AEs)
• Serious adverse events (SAEs)
  Time frame: 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)
  The occurrence of all serious adverse events (SAEs) .

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
   Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401
2. Mechanisms and Design Principles of Proteolysis-Targeting Chimeras and Their Emerging Applications.
   Knoll N, Neamati N, Üren A. · · 2026 · PMID 41988372 · DOI 10.1021/acsptsci.5c00730