TQB3205 capsules for adults 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

TQB3205 capsules will be tested for safety, tolerability, and how the drug is processed in the body in adults with advanced malignant tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07482592 on ClinicalTrials.gov

What this trial studies

This is a phase 1, single-center, open-label, non-randomized, single-arm trial using dose-escalation and dose-expansion cohorts to study oral TQB3205 capsules. The trial includes single-dose and continuous-dosing schedules to characterize safety, tolerability, and pharmacokinetics, with preliminary measures of antitumor activity. Eligible participants are adults with advanced malignant tumors, ECOG 0-1, measurable disease, and adequate organ function. Study visits and dosing occur at Tianjin Medical University Cancer Institute & Hospital.

Who should consider this trial

Good fit: Adults (≥18 years) with advanced malignant tumors, ECOG performance status 0–1, at least one measurable lesion, adequate organ function, and expected survival of at least three months are the intended participants.

Not a fit: Patients with poor performance status, significant organ dysfunction, very limited life expectancy, recent major surgery, or who are pregnant are unlikely to be eligible or to receive benefit from this phase 1 safety-focused trial.

Why it matters

Potential benefit: If successful, TQB3205 could become a new oral treatment option that may slow tumor growth or offer clinical benefit for some people with advanced cancers.

How similar studies have performed: This is an early-phase first-in-human design; while some novel oral anticancer agents have advanced from phase 1 to later success, many early-phase agents do not demonstrate later clinical benefit.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jihui Hao, Doctor

Conditions Advanced Malignant Cancer