Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830501
• Other study ID #: TT00434CN01
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2021
• Est. completion date: October 18, 2023

Study information

• Verified date: November 2023
• Source: TransThera Sciences (Nanjing), Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.

Description:

This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age = 20 years.

• Patients must have a histological or cytologically confirmed diagnosis of advanced or recurrent malignant solid tumors.

• Patients have received all currently available standard treatments (unless the therapy is contraindicated, intolerable or unavailable due to any reasons).

• Patients must have measurable or evaluable disease (according to RECIST 1.1)

• Eastern Cooperative Oncology Group (ECOG) Performance Status = 2

• Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment

• Patients must have fully understood and voluntarily signed informed consent form (ICF) for this study.

Exclusion Criteria:

• Patients who received other investigational products or devices in other clinical trials within 4 weeks before the first dose.

• Patients who received anti-tumor therapy within 4 weeks, or within 5-half-lives (which is longer) before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enrol), targeted therapy or immunotherapy.

• Patients who have previous toxicity of anti-tumor therapy that has not recovered to Grade 1. (except for = Grade 2 alopecia, chemotherapy-induced peripheral neurotoxicity, and ototoxicity).

• Patients who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of TT-00434 will be interfered.

• Patients underwent major surgery (except biopsy) within 4 weeks, or the surgical incision has not completely healed prior to the first dose.

• Patients who have active bacterial or fungal infections (CTCAE, Grade = 2) that required systemic treatment within 2 weeks prior to the first dose.

• Patients who have active HBV infection (HBV DNA copies = ULN) and/or HCV infection (HCV RNA copies = ULN)

• Patients who test positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.

• Has received a live-virus vaccination within 30 days of planned first dose NOTE:

Seasonal flu vaccines are permitted.

• Known or suspected drug hypersensitivity to any ingredients of TT-00434 tablets.

• Female patients in pregnancy or lactation. Male patients or female patients at reproductive ages who are unwilling to receive effective contraceptive measures.

• Patients who are judged by the Investigator to be unsuitable for this study.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• TT-00434
Once daily [QD], 28 days/cycle.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TransThera Sciences (Nanjing), Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	Safety and tolerability	At the end of Cycle 1 (each cycle is 28 days)
Primary	Incidence of AEs	Safety and tolerability	up to 30 days from study discontinuation
Secondary	Peak Plasma Concentration (Cmax)	PK evaluation	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Area under the plasma concentration versus time curve (AUC)	PK evaluation	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Time of first Occurance of Cmax(tmax)	PK evaluation	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Serum phosphate levels	PD biomarker	up to 30 days from study discontinuation
Secondary	Objective response rate (ORR)	Assess anti-tumor activity	through study completion, an average of 1 year
Secondary	Disease control rate (DCR)	Assess anti-tumor activity	through study completion, an average of 1 year
Secondary	Progression Free Survival (PFS)	Assess anti-tumor activity	through study completion, an average of 1 year
Secondary	Overall Survival (OS)	Assess anti-tumor activity	through study completion, an average of 1 year