This is a first-in-human, multicenter, open-label, single-arm Phase I study of FXS0683 in participants with relapsed or refractory hematologic malignancies to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity, and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
This is a first-in-human, multicenter, open-label, single-arm Phase I study of FXS0683 tablets in participants with relapsed or refractory hematologic malignancies, designed to evaluate safety, tolerability, PK, and preliminary antitumor activity.The study consists of a dose-escalation phase and a dose-expansion phase. The primary objective of dose escalation is to assess safety and tolerability and to determine the MTD and/or RP2D. Dose escalation will follow an accelerated titration design combined with a Bayesian Optimal Interval (BOIN) design. The initial cohort will enroll one participant; if a treatment-related adverse event of Grade ≥2 occurs during the dose-limiting toxicity (DLT) observation period, the cohort will transition to a BOIN design and expand to include additional participants. Dose escalation may proceed in the absence of DLTs among evaluable participants. The dose-expansion phase is intended to further evaluate safety and preliminary efficacy at selected dose level(s). Expansion may be initiated based on emerging safety, tolerability, and PK data from the dose-escalation phase without requiring completion of all escalation cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
228
FXS0683 is a potent and highly selective BCL-2 inhibitor
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, Tianjin Municipality, China
Number of participants with DLTs
A DLT is defined as any adverse event or laboratory abnormality occurring during the DLT observation period that is assessed as at least possibly related to FXS0683 and meets pre-specified DLT criteria, graded per NCI-CTCAE Version 6.0.
Time frame: At the end of Cycle 1 (each cycle is 28 days).
MTD and/or RP2D
The MTD and/or RP2D will be determined based on the overall assessment of safety, tolerability, PK, and preliminary efficacy data.
Time frame: Up to approximately 3 years.
Incidence and Severity of Adverse Events and Clinically Significant Safety Findings
Adverse events (AEs) will be summarized, and severity will be graded according to NCI-CTCAE Version 6.0.
Time frame: From first dose of study drug until 30 days after the last dose.
Objective Response Rate (ORR) Of FXS0683 Monotherapy
ORR will be assessed according to disease-specific response criteria (e.g., Lugano 2014, iwCLL 2018, ELN 2022, or IWG 2006), as applicable.
Time frame: Up to approximately 3 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.