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).
Voluntary participation in the clinical trial and signing of the ICF.
Age ≥ 18 years, regardless of gender.
Dose escalation phase: Patients with mature B-cell malignancies diagnosed per the 2017 WHO classification who have failed standard therapies and have no appropriate treatment options. Dose expansion phase: Patients with B-cell lymphoma (2017 WHO), myeloid malignancies (2022 WHO), or acute lymphoblastic leukemia.
Dose escalation phase: Evaluable disease. Dose expansion phase: For B-cell lymphoma, at least one measurable lesion per Lugano 2014 criteria.
Burkitt lymphoma/leukemia, plasma cell myeloma, or plasmablastic lymphoma.
Acute promyelocytic leukemia (APL) or BCR-ABL positive AML patients, or patients with a history of myeloproliferative neoplasms (MPN).
Use of cytotoxic agents, investigational drugs, or other antitumor therapies within 14 days or 5 half-lives prior to the first dose; or immunotherapy, antibody-based or peptide-based therapies, or live vaccines within 4 weeks prior to the first dose.
Patients who received any therapeutic surgery other than diagnosis, biopsy, or drainage within 4 weeks before the first dose, or patients expected to undergo major surgery during the study. Patients who underwent drainage or placement of drainage tubes within 4 weeks before the first dose must have symptoms/signs alleviated and not require prophylactic or therapeutic antibiotics.
Single group
FXS0683
Biological/VaccineFXS0683 is a potent and highly selective BCL-2 inhibitor
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
