Clinical trial NCT05649345: TR64 in Patients With Advanced Solid Tumors
Official title: A Single-arm, Open-Label, Dose Escalation , Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR64 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Tarapeutics Science Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.

Detailed description: Patients will receive study treatment until criteria for study termination are met. A Safety Follow-up Visit will be conducted 28 days (±7 days) after the last dose of study treatment. Patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

Tumor response will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator.

Eligibility criteria: Inclusion Criteria:

* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
* Males and/or females at least 18 years old when signing the informed consent form.
* Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator.
* Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
* Life expectancy of at least 3 months.
* Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L; Platelet count(PLT)≥90×109/L; Hemoglobin(Hb)≥90 g/L; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤2.5×ULN; Aspartate aminotransferase(AST)≤2.5×ULN; Creatinine clearance ≥50ml/min.
* Fertile male and female must agree to use medically approved contraceptives during the study and within 90 days after the last dose of the study.

Exclusion Criteria:

* Known or suspected allergies to any of the investigational drug composition.
* Medical history and surgical history excluded according to the protocol.
* Any previous medical treatment history exclude from the protocol.
* Abnormal laboratory results exclude from the protocol.
* pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding).
* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.

Primary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: From the first dose to within 28 days after the last dose
measure: Dose limited toxicities
timeFrame: within 28 days after the first dose
measure: Maximum tolerated dose
timeFrame: Throughout the study for approximately 2 years
measure: Recommended phaseII dose
timeFrame: Throughout the study for approximately 2 years
Secondary outcomes:
measure: AUClast
timeFrame: within 35 days after the first dose
measure: AUCinf
timeFrame: within 35 days after the first dose
measure: Cmax
timeFrame: within 35 days after the first dose
measure: Tmax
timeFrame: within 35 days after the first dose
measure: CL/F
timeFrame: within 35 days after the first dose
measure: Vz/F
timeFrame: within 35 days after the first dose
measure: Terminal half-life (T1/2)
timeFrame: within 35 days after the first dose
Other outcomes:
measure: ORR
timeFrame: Throughout the study for approximately 2 years
measure: PFS
timeFrame: Throughout the study for approximately 2 years
measure: DOR
timeFrame: Throughout the study for approximately 2 years
measure: CBR
timeFrame: Throughout the study for approximately 2 years
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Bengbu Medical University
name: Huan Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Funan Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: