Phase I Study of FXS0683 in the Treatment of Blood Tumors

NCT07616089 | Not Yet Recruiting Phase 1

• 1 other identifier: FXS0683-001
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

B-Cell Lymphoma; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 3 years.

Secondary Outcomes (2)

• Incidence and Severity of Adverse Events and Clinically Significant Safety Findings

  From first dose of study drug until 30 days after the last dose.

• Objective Response Rate (ORR) Of FXS0683 Monotherapy

  Up to approximately 3 years.

Study Arms (1)

FXS0683

EXPERIMENTAL

This is a first-in-human, multicenter, open-label, single-arm Phase I study consisting of dose-escalation and dose-expansion phases. FXS0683 will be administered orally once daily at assigned dose levels in 28-day cycles.

Biological: FXS0683

Interventions

FXS0683 BIOLOGICAL

FXS0683 is a potent and highly selective BCL-2 inhibitor

FXS0683

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be willing to undergo bone marrow aspiration and/or biopsy.
• ECOG performance status of 0-1 (dose escalation phase) or 0-2 (dose expansion phase).
• Expected survival time ≥3 months.
• Adequate bone marrow function during screening, as defined by local laboratory reference ranges, without growth factor support.
• Adequate organ function, defined by laboratory values within 7 days prior to the first dose.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception from signing the ICF until 6 months after the last dose.
• Patients at high risk of tumor lysis syndrome (TLS), defined as absolute lymphocyte count (ALC) ≥25×10⁹/L with ≥1 measurable lymph node ≥5 cm or any node ≥10 cm, must be willing to comply with TLS prophylaxis and monitoring requirements.
• Patients must be able to comply with the study procedures and visit schedule.

You may not qualify if:

• 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.
• Patients who received systemic radiotherapy or palliative local radiotherapy within 4 weeks before the first dose.
• Toxicity from previous anticancer treatment has not recovered to ≤ grade 2, except for hair loss and pigmentation.
• Prior allogeneic stem cell transplantation; or autologous stem cell transplantation or CAR-T therapy within 3 months prior to the first dose.
• Patients with lymphoma/leukemia that has infiltrated the central nervous system.
• Patients with dysphagia or a history of severe gastrointestinal diseases and whose related symptoms cannot be reasonably controlled; or patients with gastrointestinal diseases affecting drug absorption or other malabsorption conditions.
• Active or clinically significant cardiovascular or cerebrovascular disease.
• Patients with interstitial lung disease or a history of pulmonary interstitial fibrosis; or evidence of active pneumonia found on screening chest CT scan.
• Patients with congenital immunodeficiency disorders or active autoimmune diseases, including but not limited to those with active and uncontrolled autoimmune cytopenias lasting ≥2 weeks, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
• Patients with coagulation disorders.
• Patients with a history of severe allergies or allergies to any active or inactive component of the study drug.
• Patients with uncontrolled systemic infections within 2 weeks before the first dose; hepatitis B surface antigen positive with hepatitis B virus DNA \>1000 IU/ml; HCV antibody positive with HCV RNA positive; HIV antibody positive.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Tianjin, Tianjin Municipality, 301600, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Leukemia; Hematologic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid

Central Study Contacts

Lugui Qiu

CONTACT

86 022-23608108; qiulg@ihcams.ac.cn

Bo Jiang

CONTACT

86 022-23608381; jiangbo@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): August 8, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CN (1)