Phase I Study of FXS0683 in the Treatment of Blood Tumors (NCT07616089) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Study of FXS0683 in the Treatment of Blood Tumors
China228 participantsStarted 2026-06-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with DLTs
Timeframe: At the end of Cycle 1 (each cycle is 28 days).
2
MTD and/or RP2D
Timeframe: Up to approximately 3 years.
Trial details
NCT IDNCT07616089
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
. Adequate bone marrow function during screening, as defined by local laboratory reference ranges, without growth factor support.
Exclusion 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.
. 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.