Clinical Trial of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

Phase I Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3205 Capsule 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 TQB3205 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3205 capsules.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Cancer
• Intervention / Treatment: Drug: TQB3205 capsules

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jihui Hao, Doctor; Phone Number: 022-23340123-3070; Email: haojihui@tjmuch.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Jihui Hao, Doctor; Phone Number: 022-23340123-3070; Email: haojihui@tjmuch.com

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: 0-1; at least 3 months expected survival period.
• At least 1 measurable lesion for efficacy evaluation.
• The function of main organs is normal.
• Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

• Individuals who have undergone major surgical treatment, significant traumatic injury, or major surgery during the expected study treatment period within 4 weeks prior to the first medication (excluding surgeries specified in the protocol), or have long-term untreated wounds or fractures. (Major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition);
• Subjects who experience any bleeding or bleeding events ≥ CTC AE grade 3 within 4 weeks prior to the first administration.
• Active syphilis infected individuals in need of treatment
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
• History of hepatic encephalopathy;
• Active or uncontrolled infections (≥ CTC AE level 2 infection);
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
• Individuals with epilepsy who require treatment;
• Poor control of diabetes (assessed by the investigator);
• Known to be allergic to research drugs or excipients;
• Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;
• According to the researcher's judgment, there is a situation that seriously endangers the safety of the subjects or affects their ability to complete the study.

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: TQB3205 capsules; 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

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) 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.	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.	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	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).	Baseline up to 24 months
The occurrence of all adverse events (AEs)	The occurrence of all adverse events (AEs)	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).	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 .	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	The proportion of subjects with best response of Complete response, partial response, Very good partial response, and Minimal response.	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	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.	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.	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.	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.	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.	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	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.	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.	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.	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	From the date of first medication use to the date of death from any cause, assessed up to 100 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TQB3205-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