A Phase 1 interventional study of TQB3205 capsules in Advanced Malignant Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
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 TQB3205 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3205 capsules.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single or continuous administration, 6-36 mg each time; TQB3205 capsule is taken orally once a day on an empty stomach, and each cycle is 21 days.
Drug: TQB3205 capsules
TQB3205 capsule is a targeted protein degrader
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) version6.0 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.
Time frame: At the end of Cycle 1 (each cycle is 21 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.
Time frame: At the end of Cycle 1 (each cycle is 21 Days)
Recommended Phase II Dose (RP2D)
RP2D describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3205 capsules in adult patients with Advanced Malignant Cancer
Time frame: Baseline up to 24 months
Maximum assessed dose (MAD)
Recommendations made by the investigator and sponsor based on clinical safety, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) data will be considered the highest dose level to complete dose exploration in the absence of an Maximum Tolerated Dose (MTD).
Time frame: Baseline up to 24 months
The occurrence of all adverse events (AEs)
The occurrence of all adverse events (AEs)
Time frame: From the time the subject receives TQB3205 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)
The occurrence of all serious adverse events (SAEs).
Time frame: From the time the subject receives TQB3205 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years)
Number of subjects with abnormal incidence of laboratory test indicators
Number of subjects with abnormal incidence and severity of laboratory test indicators .
Time frame: From the time the subject receives TQB3205 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, partial response, Very good partial response, and Minimal response.
Time frame: 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
Tmax
Time to Reach the Maximum Plasma Concentration
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Cmax
Cmax is the maximum plasma concentration of TQB3205.
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Elimination half-life (t1/2)
To evaluate the elimination half-life (t1/2) after oral dose of TQB3205 capsules to subjects.
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB3205 by assessment of area under the plasma concentration time curve from the first dose to a certain time.
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Apparent clearance (CL/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Apparent volume of distribution (Vd/F)
Apparent volume of distribution of the TQB3205 in plasma.
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
Minimum concentration (Cminutes)
Minimum observed concentration (Cminutes) of TQB3205
Time frame: Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle)
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.
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
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.
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
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.
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks
Overall Survival (OS)
The time from start of study treatment to date of death due to any cause
Time frame: From the date of first medication use to the date of death from any cause, assessed up to 100 weeks
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.