Phase I Study of FXS0683 in the Treatment of Blood Tumors

Sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Study ID
NCT07616089
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FXS0683 — BIOLOGICAL
    FXS0683 is a potent and highly selective BCL-2 inhibitor

Study Details

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).

Key Dates

First listed
May 29, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Aug 7, 2028
Completion
Aug 8, 2029

Study Design

Enrollment
228 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FXS0683
    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.

Primary Outcome Measure

Number of participants with DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 28 days). ]

Central Contacts

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