NCT05275504

Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

A Phase I, First-In-Human, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.

Detailed description

The study will consist of two parts, dose escalation and dose expansion. A modified 3+3 design will be used to guide the dose escalation and the determination of the dose recommended for dose expansion (DRDE). A sentinel cohort comprising of one subject will be enrolled at a starting dose of 50 mg q.d. Subsequently, patients will be enrolled according to the standard 3+3 dose escalation design to determine the DRDE. Once the DRDE has been selected, TT-01488 of DRDE will be further tested in the dose expansion cohort to verify the safety and preliminary efficacy as observed in the dose escalation cohorts. A recommended Phase II dose (RP2D) may be determined based on the totality of safety, pharmacokinetics, and efficacy data from the dose escalation cohorts and dose expansion cohort.

Conditions

• B-Cell Malignancies

Interventions

Type	Name	Description
DRUG	TT-01488	TT-01488 tablet will be administered orally once daily per protocol defined schedule.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-09-01
• Completion: 2023-04-01
• First posted: 2022-03-11
• Last updated: 2022-06-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study