Clinical Trial of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

Official title

Phase I Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

Overview

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.

Interventions

• Drug TQB3205 capsules
  TQB3205 capsule is a targeted protein degrader

Primary outcome measures

• Dose Limiting Toxicity (DLT) [Time frame: At the end of Cycle 1 (each cycle is 21 Days)]
• Maximum tolerated dose (MTD) [Time frame: At the end of Cycle 1 (each cycle is 21 Days)]
• Recommended Phase II Dose (RP2D) [Time frame: Baseline up to 24 months]
• Maximum assessed dose (MAD) [Time frame: Baseline up to 24 months]
• 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) [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 [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)]

Secondary outcome measures (12)

• Overall response rate (ORR) [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 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 [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) [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) [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) [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) [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) [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) [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) [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) [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) [Time frame: From the date of first medication use to the date of death from any cause, assessed up to 100 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT07482592 · TQB3205-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗