TR64 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649345
• Other study ID #: TR64-CN-PI-01
• Status: Recruiting
• Phase: Phase 1
• Start date: January 12, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: Tarapeutics Science Inc.
• Contact: Yang Shu, MD. BS.
• Phone: 86-13918983465
• Email: shuyang[@]tarapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: December 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• TR64
TR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Tarapeutics Science Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ORR	Efficacy-Overall Response Rate	Throughout the study for approximately 2 years
Other	PFS	Efficacy-Progression Free Survival	Throughout the study for approximately 2 years
Other	DOR	Efficacy-Duration of Response	Throughout the study for approximately 2 years
Other	CBR	Efficacy-Clinical Benefit Rate	Throughout the study for approximately 2 years
Primary	Adverse Events and Serious Adverse Events	Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0	From the first dose to within 28 days after the last dose
Primary	Dose limited toxicities	Incidence of dose limited toxicities	within 28 days after the first dose
Primary	Maximum tolerated dose	Evaluated by safety review committee	Throughout the study for approximately 2 years
Primary	Recommended phaseII dose	Evaluated by safety review committee	Throughout the study for approximately 2 years
Secondary	AUClast	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	AUCinf	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	Cmax	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	Tmax	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	CL/F	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	Vz/F	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose
Secondary	Terminal half-life (T1/2)	Characterize the pharmacokinetic profile of TR64	within 35 days after the first dose